Dose detection system module for medication delivery device

ABSTRACT

Dose detection systems for medication delivery devices are described. One is a module for removable attachment to a dose button of a medication delivery device. A device with a dose detection system is also disclosed. The module includes a processor and a plurality of magnetic sensors, such as, for example, five or six sensors, operably coupled to the processor and configured to detect the positon of a rotating bipolar magnetic ring within the delivery device. Medication identification system may also be provided.

TECHNICAL FIELD

The present disclosure relates to an electronic dose detection systemfor a medication delivery device, and illustratively to an electronicdose detection module adapted to removably attach to a proximal endportion of a medication delivery device. The dose delivery detectionsystem is operable to detect the amount of a dose of medicationdelivered by the medication delivery device and/or the type ofmedication contained in the medication delivery device.

BACKGROUND

Patients suffering from various diseases must frequently injectthemselves with medication. To allow a person to conveniently andaccurately self-administer medicine, a variety of devices broadly knownas pen injectors or injection pens have been developed. Generally, thesepens are equipped with a cartridge including a piston and containing amulti-dose quantity of liquid medication. A drive member is movableforward to advance the piston in the cartridge to dispense the containedmedication from an outlet at the distal cartridge end, typically througha needle. In disposable or prefilled pens, after a pen has been utilizedto exhaust the supply of medication within the cartridge, a userdiscards the entire pen and begins using a new replacement pen. Inreusable pens, after a pen has been utilized to exhaust the supply ofmedication within the cartridge, the pen is disassembled to allowreplacement of the spent cartridge with a fresh cartridge, and then thepen is reassembled for its subsequent use.

Many pen injectors and other medication delivery devices utilizemechanical systems in which members rotate and/or translate relative toone another in a manner proportional to the dose delivered by operationof the device. Accordingly, the art has endeavored to provide reliablesystems that accurately measure the relative movement of members of amedication delivery device in order to assess the dose delivered. Suchsystems may include a sensor which is secured to a first member of themedication delivery device, and which detects the relative movement of asensed component secured to a second member of the device.

The administration of a proper amount of medication requires that thedose delivered by the medication delivery device be accurate. Many peninjectors and other medication delivery devices do not include thefunctionality to automatically detect and record the amount ofmedication delivered by the device during the injection event. In theabsence of an automated system, a patient must manually keep track ofthe amount and time of each injection. Accordingly, there is a need fora device that is operable to automatically detect the dose delivered bythe medication delivery device during an injection event. Further, thereis a need for such a dose detection device to be removable and reusablewith multiple delivery devices. In other embodiments, there is a needfor such a dose detection device to be integral with the deliverydevice.

It is also important to deliver the correct medication. A patient mayneed to select either a different medication, or a different form of agiven medication, depending on the circumstances. If a mistake is madeas to which medication is in the medication delivery device, then thepatient will not be properly dosed, and records of dose administrationwill be inaccurate. The potential for this happening is substantiallydiminished if a dose detection device is used which automaticallyconfirms the type of medication contained by the medication deliverydevice.

SUMMARY

In one embodiment, a medication delivery device including a rotatablesensed element that may be utilized as part of a dose detection systemis disclosed. An annular sensed element, such as a metal ring, amagnetic ring, or others, is positioned on a proximal surface of a dosesetting component. The dose setting component is coupled to a devicebody and rotatable relative thereto in relation to an amount of a setand/or delivered dose. A carrier can axially and rotationally fixed thesensed element to the dose setting component. The carrier includes aproximal overlapping support contactable against the annular sensedelement opposite the proximal surface of the dose setting component. Insome embodiments, the carrier may be configured with elements to help inits attachment to the dose setting component. In some embodiments, thesensed element is coupled to the dose setting member without anadhesive.

Another embodiment disclosed is a method of coupling a sensed element toa dose setting component of a medication delivery device. Steps include:providing a carrier and an annular sensed element, the carrier includinga tubular body sized to fit within the annular sensed element, aproximal lip extending radially beyond the tubular body, and a pluralityof coupling legs extending distally from the tubular body away from theproximal lip; coupling the annular sensed element over the tubular bodyof the carrier and in contact underneath the proximal lip; and couplingthe carrier with the annular sensed element to the dose settingcomponent for sandwiching the annular sensed element between the radiallip and the proximal surface of the dose setting component, where thecoupling legs of the carrier is engaged with the dose setting componentto rotationally lock the carrier with the annular sensed element to thedose setting component.

BRIEF DESCRIPTION OF THE DRAWINGS

The features and advantages of the present disclosure will become moreapparent to those skilled in the art upon consideration of the followingdetailed description taken in conjunction with the accompanying figures.

FIG. 1 is a perspective view of an exemplary medication delivery devicewith which the dose detection system of the present disclosure isoperable.

FIG. 2 is a cross-sectional perspective view of the exemplary medicationdelivery device of FIG. 1.

FIG. 3 is a perspective view of the proximal portion of the exemplarymedication delivery device of FIG. 1.

FIG. 4 is a partially-exploded, perspective view of the proximal portionof the exemplary medication delivery device of FIG. 1, together with adose detection system of the present disclosure.

FIG. 5 is a side, diagrammatic view, partially in cross section, of adose detection system module according to another exemplary embodimentattached to the proximal portion of a medication delivery device.

FIG. 6 is a cross-sectional view of a module of a dose detection systemaccording to an exemplary embodiment attached to the proximal portion ofa medication delivery device.

FIG. 7 is a top, diagrammatic view showing rotation sensors positionedto detect magnetic sensed elements attached to a dose setting member inaccordance with an exemplary embodiment.

FIG. 8 is a perspective view of the dose setting member of FIG. 7including the magnetic sensed elements.

FIG. 9 is a perspective view of an alternate embodiment of a magneticdose detection system.

FIGS. 10A-B and 11A-B show yet other exemplary embodiments of dosedetection systems utilizing magnetic sensing.

FIG. 12 is cross-sectional view of a dose detection system according toanother embodiment, in which the sensor and sensed element areintegrated into a medication delivery device.

FIG. 13 is a side, diagrammatic cross-sectional view of a dose detectionsystem module according to another exemplary embodiment attached to theproximal portion of a medication delivery device.

FIG. 14 is a perspective view of an example of a dose button for amedication delivery device.

FIG. 15 is a perspective view of a subassembly of a module housing ofthe dose detection system module in FIG. 13.

FIG. 16 is a perspective proximal view of a component of the subassemblyin FIG. 15.

FIG. 17 is a distal view of the component in FIG. 15.

FIG. 18 is a perspective view of another example of a dose button for amedication delivery device.

FIG. 19 is a perspective view of another example of a dose button for amedication delivery device.

FIG. 20 is a perspective view of a subassembly of a module housing ofanother example of a dose detection system module mounted to anotherexample of a dose button for a medication delivery device.

FIG. 21 is a perspective view of the subassembly of the module housingof the dose detection system module removed from the dose button.

FIG. 22 is a perspective view of the dose button in FIG. 20.

FIG. 23 is a cross-sectional view of the subassembly of the modulehousing in FIG. 20.

FIG. 24 is a cross-sectional view of the subassembly of the modulehousing of the dose detection system module mounted to the dose buttonin FIG. 20.

FIGS. 25-26 are side, diagrammatic cross-sectional views of a dosedetection system module according to another exemplary embodimentattached to the proximal portion of a medication delivery device.

FIG. 27 is a perspective proximal view of an example of an electronicsassembly of a dose detection system module.

FIG. 28 is a cross-sectional axial view taken along lines 28-28 in FIG.25.

FIG. 29 is a perspective distal view of the electronics assembly in FIG.27.

FIG. 30 is a perspective piece part exploded view of a subassembly of aproximal portion of a medication delivery device.

FIG. 31 is a side, diagrammatic view, partially in cross section, of aproximal portion of the subassembly in FIG. 30 assembled.

FIG. 32 is a perspective proximal view of a flange, a carrier, and arotation sensed element assembled to one another.

FIG. 33 is a perspective proximal view of the flange, the carrier, therotation sensed element, and a spring assembled.

FIG. 34 is a proximal view of the flange, the carrier, and the rotationsensed element assembled.

FIG. 35 is a cross-sectional view of another embodiment of a module of adose delivery detection system attached to the proximal portion of themedication delivery device.

FIG. 36 is a proximal axial view of the module of FIG. 35, shown withthe proximal wall assembly removed.

FIG. 37 is a perspective proximal view of a unit component of the moduleof FIG. 35.

FIG. 38 is a perspective distal partial view of the module in FIG. 35,shown with the delivery device omitted.

FIG. 39 is a perspective view a light guide member component provided inthe module of FIG. 35.

FIG. 40 is an axial view of yet other exemplary embodiment of the dosedelivery detection system utilizing magnetic sensing.

FIG. 41 is a cross-sectional view of the proximal portion of themedication delivery device and its relative position to the magneticsensing system.

FIG. 42 is a graph comparing a measured rotational magnetic fluxwaveform with a purely sinusoidal model of the magnetic flux waveformduring rotational position sensing.

FIG. 43 is a graph comparing the results of dial/dose errors contributedfrom magnetic non-uniformity and harmonic distortions from a samplenumber of N35 grade magnets made from regular production means for 4-,5- and 6-sensor architectures.

FIG. 44 is a graph comparing the results of dial/dose errors contributedfrom magnetic non-uniformity and harmonic distortions from a samplenumber of N35 high-grade magnets made from customized production for 4-,5- and 6-sensor architectures.

FIG. 45 is a graph depicting different orders of percentage of harmonicsfor lot-to-lot variation of N35 grade magnets made from regularproduction means.

FIG. 46 depicts a block diagram of the controller and its components.

FIG. 47 depicts an exploded view of the module in FIG. 35 with itscomponents axially displaced relative to one another.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of the invention is thereby intended.

The present disclosure relates to sensing systems for medicationdelivery devices. In one aspect, the sensing system is for determiningthe amount of a dose delivered by a medication delivery device based onthe sensing of relative rotational movement between a dose settingmember and an actuator of the medication delivery device. The sensedrelative angular positions or movements are correlated to the amount ofthe dose delivered. In a second aspect, the sensing system is fordetermining the type of medication contained by the medication deliverydevice. By way of illustration, the medication delivery device isdescribed in the form of a pen injector. However, the medicationdelivery device may be any device which is used to set and to deliver adose of a medication, such as an infusion pump, bolus injector or anauto injector device. The medication may be any of a type that may bedelivered by such a medication delivery device.

Devices described herein, such as a device 10, may further comprise amedication, such as for example, within a reservoir or cartridge 20. Inanother embodiment, a system may comprise one or more devices includingdevice 10 and a medication. The term “medication” refers to one or moretherapeutic agents including but not limited to insulins, insulinanalogs such as insulin lispro or insulin glargine, insulin derivatives,GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon,glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide(GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs,oxyntomodulin derivatives, therapeutic antibodies and any therapeuticagent that is capable of delivery by the above device. The medication asused in the device may be formulated with one or more excipients. Thedevice is operated in a manner generally as described above by apatient, caregiver or healthcare professional to deliver medication to aperson.

An exemplary medication delivery device 10 is illustrated in FIGS. 1-4as a pen injector configured to inject a medication into a patientthrough a needle. Pen injector 10 includes a body 11 comprising anelongated, pen-shaped housing 12 including a distal portion 14 and aproximal portion 16. Distal portion 14 is received within a pen cap 18.Referring to FIG. 2, distal portion 14 contains the reservoir orcartridge 20 configured to hold the medicinal fluid of medication to bedispensed through its distal outlet end during a dispensing operation.The outlet end of distal portion 14 is equipped with a removable needleassembly 22 including an injection needle 24 enclosed by a removablecover 25. A piston 26 is positioned in reservoir 20. An injectingmechanism positioned in proximal portion 16 is operative to advancepiston 26 toward the outlet of reservoir 20 during the dose dispensingoperation to force the contained medicine through the needled end. Theinjecting mechanism includes a drive member 28, illustratively in theform of a screw, axially moveable relative to housing 12 to advancepiston 26 through reservoir 20.

A dose setting member 30 is coupled to housing 12 for setting a doseamount to be dispensed by device 10. In the illustrated embodiment, dosesetting member 30 is in the form of a screw element operative to spiral(i.e., simultaneously move axially and rotationally) relative to housing12 during dose setting and dose dispensing. FIGS. 1 and 2 illustrate thedose setting member 30 fully screwed into housing 12 at its home or zerodose position. Dose setting member 30 is operative to screw out in aproximal direction from housing 12 until it reaches a fully extendedposition corresponding to a maximum dose deliverable by device 10 in asingle injection.

Referring to FIGS. 2-4, dose setting member 30 includes a cylindricaldose dial member 32 having a helically threaded outer surface thatengages a corresponding threaded inner surface of housing 12 to allowdose setting member 30 to spiral relative to housing 12. Dose dialmember 32 further includes a helically threaded inner surface thatengages a threaded outer surface of sleeve 34 (FIG. 2) of device 10. Theouter surface of dial member 32 includes dose indicator markings, suchas numbers that are visible through a dosage window 36 to indicate tothe user the set dose amount. Dose setting member 30 further includes atubular flange 38 that is coupled in the open proximal end of dialmember 32 and is axially and rotationally locked to dial member 32 bydetents 40 received within openings 41 in dial member 32. Dose settingmember 30 may further include a collar or skirt 42 positioned around theouter periphery of dial member 32 at its proximal end. Skirt 42 isaxially and rotationally locked to dial member 32 by tabs 44 received inslots 46. Further embodiments described later shown examples of thedevice without a skirt.

Dose setting member 30 therefore may be considered to comprise any orall of dose dial member 32, flange 38, and skirt 42, as they are allrotationally and axially fixed together. Dose dial member 32 is directlyinvolved in setting the dose and driving delivery of the medication.Flange 38 is attached to dose dial member 32 and, as described later,cooperates with a clutch to selectively couple dial member 32 with adose button 56. Skirt 42 provides a surface external of body 11 toenable a user to rotate the dial member 32 for setting a dose.

Skirt 42 illustratively includes a plurality of surface features 48 andan annular ridge 49 formed on the outer surface of skirt 42. Surfacefeatures 48 are illustratively longitudinally extending ribs and groovesthat are circumferentially spaced around the outer surface of skirt 42and facilitate a user's grasping and rotating the skirt. In analternative embodiment, skirt 42 is removed or is integral with dialmember 32, and a user may grasp and rotate dose button 56 and/or dosedial member 32 for dose setting. In the embodiment of FIG. 4, a user maygrasp and rotate the radial exterior surface of one-piece dose button56, which also includes a plurality of surface features, for dosesetting.

Delivery device 10 includes an actuator 50 having a clutch 52 which isreceived within dial member 32. Clutch 52 includes an axially extendingstem 54 at its proximal end. Actuator 50 further includes dose button 56positioned proximally of skirt 42 of dose setting member 30. In analternative embodiment, dose setting member 30 may include a one-piecedose button without the skirt, such as, for example, shown in FIGS. 14,18, 19, and 22. Dose button 56 includes a mounting collar 58 (FIG. 2)centrally located on the distal surface of dose button 56. Collar 58 isattached to stem 54 of clutch 52, such as with an interference fit or anultrasonic weld, so as to axially and rotatably fix together dose button56 and clutch 52.

Dose button 56 includes a disk-shaped proximal end surface or face 60and an annular wall portion 62 extending distally and spaced radiallyinwardly of the outer peripheral edge of face 60 to form an annular lip64 there between. Proximal face 60 of dose button 56 serves as a pushsurface against which a force can be applied manually, i.e., directly bythe user to push actuator 50 in a distal direction. Dose button 56illustratively includes a recessed portion 66 centrally located onproximal face 60, although proximal face 60 alternatively may be a flatsurface. Similarly, the alternative one-piece dose button, such as shownin FIG. 22, may include a recessed portion 66 centrally located onproximal face 60 or alternatively may be a flat surface. A bias member68, illustratively a spring, is disposed between the distal surface 70of button 56 and a proximal surface 72 of tubular flange 38 to urgeactuator 50 and dose setting member 30 axially away from each other.Dose button 56 is depressible by a user to initiate the dose dispensingoperation.

Delivery device 10 is operable in both a dose setting mode and a dosedispensing mode. In the dose setting mode of operation, dose settingmember 30 is dialed (rotated) relative to housing 12 to set a desireddose to be delivered by device 10. Dialing in the proximal directionserves to increase the set dose, and dialing in the distal directionserves to decrease the set dose. Dose setting member 30 is adjustable inrotational increments (e.g., clicks) corresponding to the minimumincremental increase or decrease of the set dose during the dose settingoperation. For example, one increment or “click” may equal one-half orone unit of medication. The set dose amount is visible to the user viathe dial indicator markings shown through dosage window 36. Actuator 50,including dose button 56 and clutch 52, move axially and rotationallywith dose setting member 30 during the dialing in the dose setting mode.

Dose dial member 32, flange 38 and skirt 42 are all fixed rotationallyto one another, and rotate and extend proximally of the medicationdelivery device 10 during dose setting, due to the threaded connectionof dose dial member 32 with housing 12. During this dose setting motion,dose button 56 is rotationally fixed relative to skirt 42 bycomplementary splines 74 of flange 38 and clutch 52 (FIG. 2), which areurged together by bias member 68. In the course of dose setting, skirt42 and dose button 56 move relative to housing 12 in a spiral mannerfrom a “start” position to an “end” position. This rotation relative tothe housing is in proportion to the amount of dose set by operation ofthe medication delivery device 10.

Once the desired dose is set, device 10 is manipulated so the injectionneedle 24 properly penetrates, for example, a user's skin. The dosedispensing mode of operation is initiated in response to an axial distalforce applied to the proximal face 60 of dose button 56. The axial forceis applied by the user directly to dose button 56. This causes axialmovement of actuator 50 in the distal direction relative to housing 12.

The axial shifting motion of actuator 50 compresses biasing member 68and reduces or closes the gap between dose button 56 and tubular flange38. This relative axial movement separates the complementary splines 74on clutch 52 and flange 38, and thereby disengages actuator 50, e.g.,dose button 56, from being rotationally fixed to dose setting member 30.In particular, dose setting member 30 is rotationally uncoupled fromactuator 50 to allow back-driving rotation of dose setting member 30relative to actuator 50 and housing 12. The dose dispensing mode ofoperation may also be initiated by activating a separate switch ortrigger mechanism.

As actuator 50 is continued to be axially plunged without rotationrelative to housing 12, dial member 32 screws back into housing 12 as itspins relative to dose button 56. The dose markings that indicate theamount still remaining to be injected are visible through window 36. Asdose setting member 30 screws down distally, drive member 28 is advanceddistally to push piston 26 through reservoir 20 and expel medicationthrough needle 24 (FIG. 2).

During the dose dispensing operation, the amount of medicine expelledfrom the medication delivery device is proportional to the amount ofrotational movement of the dose setting member 30 relative to actuator50 as the dial member 32 screws back into housing 12. The injection iscompleted when the internal threading of dial member 32 has reached thedistal end of the corresponding outer threading of sleeve 34 (FIG. 2).Device 10 is then once again arranged in a ready state or zero doseposition as shown in FIGS. 2 and 3.

The start and end angular positions of dose dial member 32, andtherefore of the rotationally fixed flange 38 and skirt 42, relative todose button 56 provide an “absolute” change in angular positions duringdose delivery. Determining whether the relative rotation was in excessof 360° is determined in a number of ways. By way of example, totalrotation may be determined by also taking into account the incrementalmovements of the dose setting member 30 which may be measured in anynumber of ways by a sensing system.

Further details of the design and operation of an exemplary deliverydevice 10 may be found in U.S. Pat. No. 7,291,132, entitled MedicationDispensing Apparatus with Triple Screw Threads for Mechanical Advantage,the entire disclosure of which is hereby incorporated by referenceherein. Another example of the delivery device is an auto-injectordevice that may be found in U.S. Pat. No. 8,734,394, entitled “AutomaticInjection Device With Delay Mechanism Including Dual Functioning BiasingMember,” which is hereby incorporated by reference in its entirety,where such device being modified with one or more various sensor systemsdescribed herein to determine an amount of medication delivered from themedication delivery device based on the sensing of relative rotationwithin the medication delivery device.

The dose detection systems described herein use a sensing component anda sensed component attached to members of the medication deliverydevice. The term “attached” encompasses any manner of securing theposition of a component to another component or to a member of themedication delivery device such that they are operable as describedherein. For example, a sensing component may be attached to a member ofthe medication delivery device by being directly positioned on, receivedwithin, integral with, or otherwise connected to, the member.Connections may include, for example, connections formed by frictionalengagement, splines, a snap or press fit, sonic welding or adhesive.

The term “directly attached” is used to describe an attachment in whichtwo components, or a component and a member, are physically securedtogether with no intermediate member, other than attachment components.An attachment component may comprise a fastener, adapter or other partof a fastening system, such as a compressible membrane interposedbetween the two components to facilitate the attachment. A “directattachment” is distinguished from a connection where thecomponents/members are coupled by one or more intermediate functionalmembers, such as the way dial member 32 is coupled in FIG. 2 to the dosebutton 56 by a clutch 52.

The term “fixed” is used to denote that an indicated movement either canor cannot occur. For example, a first member is “fixed rotationally”with a second member if the two members are required to move together inrotation. In one aspect, a member may be “fixed” relative to anothermember functionally, rather than structurally. For example, a member maybe pressed against another member such that the frictional engagementbetween the two members fixes them together rotationally, while the twomembers may not be fixed together absent the pressing of the firstmember.

Various sensor systems are contemplated herein. In general, the sensorsystems comprise a sensing component and a sensed component. The term“sensing component” refers to any component which is able to detect therelative position of the sensed component. The sensing componentincludes a sensing element, or “sensor”, along with associatedelectrical components to operate the sensing element. The “sensedcomponent” is any component for which the sensing component is able todetect the position and/or movement of the sensed component relative tothe sensing component. For the dose delivery detection system, thesensed component rotates relative to the sensing component, which isable to detect the angular position and/or the rotational movement ofthe sensed component. For the dose type detection system, the sensingcomponent detects the relative angular position of the sensed component.The sensing component may comprise one or more sensing elements, and thesensed component may comprise one or more sensed elements. The sensorsystem is able to detect the position or movement of the sensedcomponent(s) and to provide outputs representative of the position(s) ormovement(s) of the sensed component(s).

A sensor system typically detects a characteristic of a sensed parameterwhich varies in relationship to the position of the one or more sensedelements within a sensed area. The sensed elements extend into orotherwise influence the sensed area in a manner that directly orindirectly affects the characteristic of the sensed parameter. Therelative positions of the sensor and the sensed element affect thecharacteristics of the sensed parameter, allowing a microcontroller unit(MCU) of the sensor system to determine different rotational positionsof the sensed element.

Suitable sensor systems may include the combination of an activecomponent and a passive component. With the sensing component operatingas the active component, it is not necessary to have both componentsconnected with other system elements such as a power supply or MCU.

Any of a variety of sensing technologies may be incorporated by whichthe relative positions of two members can be detected. Such technologiesmay include, for example, technologies based on tactile, optical,inductive or electrical measurements. Such technologies may include themeasurement of a sensed parameter associated with a field, such as amagnetic field. In one form, a magnetic sensor senses the change in asensed magnetic field as a magnetic component is moved relative to thesensor. In another embodiment, a sensor system may sense characteristicsof and/or changes to a magnetic field as an object is positioned withinand/or moved through the magnetic field. The alterations of the fieldchange the characteristic of the sensed parameter in relation to theposition of the sensed element in the sensed area. In such embodimentsthe sensed parameter may be a capacitance, conductance, resistance,impedance, voltage, inductance, etc. For example, a magneto-resistivetype sensor detects the distortion of an applied magnetic field whichresults in a characteristic change in the resistance of an element ofthe sensor. As another example, Hall effect sensors detect changes involtage resulting from distortions of an applied magnetic field.

In one aspect, the sensor system detects relative positions or movementsof the sensed elements, and therefore of the associated members of themedication delivery device. The sensor system produces outputsrepresentative of the position(s) or the amount of movement of thesensed component. For example, the sensor system may be operable togenerate outputs by which the rotation of the dose setting member duringdose delivery can be determined. MCU is operably connected to eachsensor to receive the outputs. In one aspect, MCU is configured todetermine from the outputs the amount of dose delivered by operation ofthe medication delivery device.

The dose delivery detection system involves detecting relativerotational movement between two members. With the extent of rotationhaving a known relationship to the amount of a delivered dose, thesensor system operates to detect the amount of angular movement from thestart of a dose injection to the end of the dose injection. For example,a typical relationship for a pen injector is that an angulardisplacement of a dose setting member of 18° is the equivalent of oneunit of dose, although other angular relationships are also suitable.The sensor system is operable to determine the total angulardisplacement of a dose setting member during dose delivery. Thus, if theangular displacement is 90°, then 5 units of dose have been delivered.

One approach for detecting the angular displacement is to countincrements of dose amounts as the injection proceeds. For example, asensor system may use a repeating pattern of sensed elements, such thateach repetition is an indication of a predetermined degree of angularrotation. Conveniently, the pattern may be established such that eachrepetition corresponds to the minimum increment of dose that can be setwith the medication delivery device.

An alternative approach is to detect the start and stop positions of therelatively moving member, and to determine the amount of delivered doseas the difference between those positions. In this approach, it may be apart of the determination that the sensor system detects the number offull rotations of the dose setting member. Various methods for this arewell within the ordinary skill in the art, and may include “counting”the number of increments to assess the number of full rotations.

The sensor system components may be permanently or removably attached tothe medication delivery device. In an illustrative embodiment, as leastsome of the dose detection system components are provided in the form ofa module that is removably attached to the medication delivery device.This has the advantage of making these sensor components available foruse on more than one pen injector.

In some embodiments, a sensing component is mounted to the actuator anda sensed component is attached to the dose setting member. The sensedcomponent may also comprise the dose setting member or any portionthereof. The sensor system detects during dose delivery the relativerotation of the sensed component, and therefore of the dose settingmember, from which is determined the amount of a dose delivered by themedication delivery device. In an illustrative embodiment, a rotationsensor is attached, and rotationally fixed, to the actuator. Theactuator does not rotate relative to the body of the medication deliverydevice during dose delivery. In this embodiment, a sensed component isattached, and rotationally fixed, to the dose setting member, whichrotates relative to the actuator and the device body during dosedelivery. The sensed component may also comprise the dose setting memberor any portion thereof. In an illustrative embodiment, the rotationsensor is not attached directly to the relatively rotating dose settingmember during dose delivery.

Referring to FIG. 5, there is shown in diagrammatic form a dose deliverydetection system 80 including one example of a module 82 useful incombination with a medication delivery device, such as device 10. Module82 carries a sensor system, shown generally at 84, including a rotationsensor 86 and other associated components such as a processor, memory,battery, etc. Module 82 is provided as a separate component which may beremovably attached to the actuator.

Dose detection module 82 includes a body 88 attached to dose button 56.Body 88 illustratively includes a cylindrical side wall 90 and a topwall 92, spanning over and sealing side wall 90. By way of example, inFIG. 5 upper side wall 90 is diagrammatically shown havinginwardly-extending tabs 94 attaching module 82 to dose button 56. Dosedetection module 82 may alternatively be attached to dose button 56 viaany suitable fastening means, such as a snap or press fit, threadedinterface, etc., provided that in one aspect module 82 may be removedfrom a first medication delivery device and thereafter attached to asecond medication delivery device. The attachment may be at any locationon dose button 56, provided that dose button 56 is able to move anyrequired amount axially relative to dose setting member 30, as discussedherein. Examples of alternative attachment elements for module 82 areshown in FIGS. 15, 23 and 37 described later.

During dose delivery, dose setting member 30 is free to rotate relativeto dose button 56 and module 82. In the illustrative embodiment, module82 is rotationally fixed with dose button 56 and does not rotate duringdose delivery. This may be provided structurally, such as with tabs 94of FIG. 5, or by having mutually-facing splines or other surfacefeatures on the module body 88 and dose button 56 engage upon axialmovement of module 82 relative to dose button 56. In another embodiment,the distal pressing of the module provides a sufficient frictionalengagement between module 82 and dose button 56 as to functionally causethe module 82 and dose button 56 to remain rotationally fixed togetherduring dose delivery.

Top wall 92 is spaced apart from face 60 of dose button 56 and therebyprovides a cavity 96 in which some or all of the rotation sensor andother components may be contained. Cavity 96 may be open at the bottom,or may be enclosed, such as by a bottom wall 98. Bottom wall 98 may bepositioned in order to bear directly against face 60 of dose button 56.Alternatively, bottom wall 98 if present may be spaced apart from dosebutton 56 and other contacts between module 82 and dose button 56 may beused such that an axial force applied to module 82 is transferred todose button 56. In another embodiment, module 82 may be rotationallyfixed to the one-piece dose button configuration, such as shown in FIG.22.

In an alternate embodiment, module 82 during dose setting is insteadattached to dose setting member 30. For example, side wall 90 mayinclude a lower wall portion 100 having inward projections 102 thatengage with skirt 42 in a position underneath ridge 49. In thisapproach, tabs 94 may be eliminated and module 82 effectively engagesthe proximal face 60 of dose button 56 and the distal side of annularridge 49. In this configuration, lower wall portion 100 may be providedwith surface features which engage with the surface features of skirt 42to rotationally fix module 82 with skirt 42. Rotational forces appliedto housing 82 during dose setting are thereby transferred to skirt 42 byvirtue of the coupling of lower wall portion 100 with skirt 42.

Module 82 is disengaged rotationally from skirt 42 in order to proceedwith dose delivery. The coupling of lower wall portion 100 with skirt 42is configured to disconnect upon distal axial movement of module 82relative to skirt 42, thereby allowing skirt 42 to rotate relative tomodule 82 during dose delivery.

In a similar fashion, module 82 may be coupled with both dose button 56and skirt 42 during dose setting. This has the advantage of providingadditional coupling surfaces during rotation of the module in dosesetting. The coupling of the module 82 to the skirt 42 is then releasedprior to dose injection, such as by the axial movement of module 82relative to skirt 42 as dose delivery is being initiated, therebyallowing dose setting member 30 to rotate relative to module 82 duringdose delivery.

In certain embodiments, rotation sensor 86 is coupled to side wall 90for detecting a sensed component. Lower wall portion 100 also serves toreduce the likelihood that a user's hand inadvertently applies drag todose setting member 30 as it rotates relative to module 82 and housing12 during dose delivery. Further, since dose button 56 is rotationallyfixed to dose setting member 30 during dose setting, the side wall 90,including lower wall portion 100, provide a single, continuous surfacewhich may be readily grasped and manipulated by the user during dosesetting.

When the injection process is initiated by pressing down on the dosedetection module 82, dose button 56 and dose setting member 30 arerotationally fixed together. Movement of module 82, and therefore dosebutton 56, a short distance, for example less than 2 mm, releases therotational engagement and the dose setting member 30 rotates relative tomodule 82 as the dose is delivered. Whether by use of a finger pad orother triggering mechanism, the dose detection system is activatedbefore the dose button 56 has moved a sufficient distance to disengagethe rotational locking of the dose button 56 and the dose setting member30.

Illustratively, the dose delivery detection system includes anelectronics assembly suitable for operation of the sensor system asdescribed herein. Electronics assembly is operably connected to thesensor system to receive outputs from one or more rotational sensors.Electronics assembly may include conventional components such as aprocessor, power supply, memory, microcontrollers, etc. contained forexample in cavity 96 defined by module body 88. Alternatively, at leastsome components may be provided separately, such as by means of anexternal device such as a computer, smart phone or other device. Meansare then provided to operably connect the external controller componentswith the sensor system at appropriate times, such as by a wired orwireless connection.

An exemplary electronics assembly 120 comprises a flexible printedcircuit board (FPCB) having a plurality of electronic components. Theelectronics assembly comprises a sensor system including one or morerotation sensors 86 operatively communicating with a processor forreceiving signals from the sensor representative of the sensed relativerotation. The electronics assembly further includes the MCU comprisingat least one processing core and internal memory. One example of anelectronics assembly schematic is shown in FIG. 46. The system includesa battery, illustratively a coin cell battery, for powering thecomponents. The MCU includes control logic operative to perform theoperations described herein, including detecting a dose delivered bymedication delivery device 10 based on a detected rotation of the dosesetting member relative to the actuator. In one embodiment, the detectedrotation is between the skirt 42 and the dose button 56 of a peninjector.

The MCU is operative to store the detected dose in local memory (e.g.,internal flash memory or on-board EEPROM). The MCU is further operativeto wirelessly transmit and/or receive a signal representative of thedetected dose to a paired remote electronic device, such as a user'ssmartphone, over a Bluetooth low energy (BLE) or other suitable short orlong range wireless communication protocol. Illustratively, the BLEcontrol logic and MCU are integrated on a same circuit. Furtherdescription of the electronics arrangement is described further below.

Much of the sensing electronics is contained in the cavity 96. However,the rotation sensor may be positioned in a variety of locations in orderto sense the relative movement of the sensed component. For example, therotation sensor may be located within cavity 96, within body 88 butoutside of the cavity 96, or in other locations of the body, such as onlower wall portion 100. The only requirement is that the rotation sensorbe positioned to effectively detect the rotational movement of thesensed component during dose delivery. In some embodiments, the rotationsensor is integral to the device 10.

One or more sensed elements are attached to the dose setting member 30.In one aspect, the sensed elements are directly attached to skirt 42 ofthe dose setting member. Alternatively, sensed elements may be attachedto any one or more of the dose setting components, including the dialmember, flange and/or skirt. The only requirement is that the sensedelement(s) be positioned to be sensed by the rotation sensor duringrelative rotational movement during dose delivery. In other embodiments,the sensed component comprises the dose setting member 30 or any portionthereof.

Further illustrative embodiments of a dose delivery detection system 80are provided in FIGS. 6-13. The embodiments are shown in somewhatdiagrammatic fashion, as common details have already been provided withrespect to FIGS. 1-5. In general, each embodiment includes similarcomponents of the dose detection module 82, including a body 88 having acylindrical upper wall 90 and a top wall 92. Each embodiment alsoincludes a lower wall 100, although it will be appreciated thatvariations on these components, including the absence of lower wall 100,are within the scope of the disclosure. Other parts common to theearlier descriptions herein include an electronics assembly 120contained within cavity 96 of module body 88, dose button 56, dosesetting member 32 and device housing 12. Further, in each embodiment thedose detection module 82 is diagrammatically shown as being attached tothe annular side wall 62 of dose button 56, although alternative formsand locations of attachment may be used. For example, dose detectionmodule 82 may be attached to dose button 56 and releasably attached toskirt 42 in some embodiments. Also, dose detection module 82 may beattached to one-piece dose button, such as shown in FIGS. 22 and 35.

Each example also demonstrates the use of a particular type of sensorsystem. However, in some embodiments the dose detection system includesmultiple sensing systems using the same or different sensingtechnologies. This provides redundancy in the event of failure of one ofthe sensing systems. It also provides the ability to use a secondsensing system to periodically verify that the first sensing system isperforming appropriately.

In certain embodiments, as shown in FIG. 6, attached to top wall 92 ofmodule 82 is a finger pad 110. Finger pad 110 is coupled to top wall 92,which is in turn attached to upper side wall 90. Finger pad 110 includesa ridge 114 which extends radially inward and is received withincircumferential groove 116 of wall component 92. Groove 116 allows aslight axial movement between finger pad 110 and wall component 92.Springs (not shown) normally urge finger pad 110 upwardly away from wallcomponent 92. Finger pad 110 may be rotationally fixed to wall component92. Axial movement of finger pad 110 in the distal direction towardmodule body 88 as the injection process is initiated may be used totrigger selected events. One use of finger pad 110 may be the activationof the medication delivery device electronics upon initial pressing andaxial movement of the finger pad 110 relative to the module body 88 whendose injection is initiated. For example, this initial axial movementmay be used to “wake up” the device, and particularly the componentsassociated with the dose detection system. In one example, module 82includes a display for indication of information to a user. Such adisplay may be integrated with finger pad 110. MCU may include a displaydrive software module and control logic operative to receive andprocessed sensed data and to display information on said display, suchas, for example, dose setting, dosed dispensed, status of injection,completion of injection, date and/or time, or time to next injection.

In the absence of a finger pad, the system electronics may be activatedin various other ways. For example, the initial axial movement of module82 at the start of dose delivery may be directly detected, such as bythe closing of contacts or the physical engagement of a switch. It isalso known to activate a medication delivery device based on variousother actions, e.g., removal of the pen cap, detection of pen movementusing an accelerometer, or the setting of the dose. In many approaches,the dose detection system is activated prior to the start of dosedelivery.

Referring to FIGS. 6-8, dose detection module 82 operates using amagnetic sensing system 84. Two magnetic sensors 130 are positioned onlower wall portion 100 (illustratively the inside surface of lower wallportion 100) opposite skirt 42 of dose setting member 30. As for allembodiments, the number and location of the rotation sensor(s) and thesensed element(s) may be varied. For example, the embodiment of FIGS.6-8 may instead include any number of magnetic sensors 130 evenly orunevenly spaced around skirt 42. The sensed component 132 (FIGS. 7 and8) comprises a magnetic strip 134 secured to skirt 42, illustratively onthe interior of skirt 42. In the illustrative embodiment, the stripcomprises 5 pairs of north-south magnetic components, e.g., 136 and 138,each magnetic portion therefore extending for 36°. The magnetic sensors130 are positioned at a separation of 18° (FIG. 7), and read the digitalpositions of magnetic strip 132, and therefore of skirt 42, in a 2-bitgrey code fashion. For example, as the sensor detects the passage of anN-S magnetic pair, it is detected that skirt 42 has rotated 36°,corresponding to 2 units, for example, of dose being added (orsubtracted).

Other magnetic patterns, including different numbers or locations ofmagnetic elements, may also be used. Further, in an alternativeembodiment, a sensed component 133 is attached to or integral withflange 38 of dose setting member 30, as illustrated in FIG. 9.

As previously described, the sensing system 84 is configured to detectthe amount of rotation of the sensed element relative to the magneticsensors 130. This amount of rotation is directly correlated to theamount of dose delivered by the device. The relative rotation isdetermined by detecting the movements of the skirt 42 during dosedelivery, for example, by identifying the difference between the startand stop positions of skirt 42, or by “counting” the number ofincremental movements of skirt 42 during the delivery of medication.

Referring to FIGS. 10A, 10B, 11A, and 11B, there is shown an exemplarymagnetic sensor system 150 including as the sensed element an annular,ring-shaped, bipolar magnet 152 having a north pole 154 and a south pole156. Magnets described herein may also be referred to as diametricallymagnetized ring. Magnet 152 is attached to flange 38 and thereforerotates with the flange during dose delivery. In one example, the magnet152 is attached to the flange 38 with an attachment carrier as shown inFIGS. 31-33. Magnet 152 may alternately be attached to dose dial 32 orother members rotationally fixed with the dose setting member. Magnet152 may configured from a variety materials, such as, rare-earthmagnets, for example, neodymium, and others a described later.

Sensor system 150 further includes a measurement sensor 158 includingone or more sensing elements 160 operatively connected with sensorelectronics (not shown) contained within module 82. The sensing elements160 of sensor 158 are shown in FIG. 11A attached to printed circuitboard 162 which is turn attached module 82, which is rotationally fixedto dose button 56. Consequently, magnet 152 rotates relative to sensingelements 160 during dose delivery. Sensing elements 160 are operable todetect the relative angular position of magnet 152. Sensing elements 160may include inductive sensors, capacitive sensors, or other contactlesssensors when the ring 152 is a metallic ring. Magnetic sensor system 150thereby operates to detect the total rotation of flange 38 relative todose button 56, and therefore the rotation relative to housing 12 duringdose delivery. In one example, magnetic sensor system 150 includingmagnet 152 and sensor 158 with sensing elements 160 may be arranged inthe modules shown in FIGS. 13, 25 and 35.

In one embodiment, magnetic sensor system 150 includes four sensingelements 160 equi-radially spaced within module 82 to define a ringpattern as shown. Alternative numbers and positions of the sensingelements may be used. For example, in another embodiment, shown in FIG.11B, a single sensing element 160 is used. Further, sensing element 160in FIG. 11B is shown centered within module 82, although other locationsmay also be used. In another embodiment, shown in FIG. 33 and FIG. 40,for example, five sensing elements 906 equi-circumferentially andequi-radially spaced within the module. In the foregoing embodiments,sensing elements 160 are shown attached within module 82. Alternatively,sensing elements 160 may be attached to any portion of a componentrotationally fixed to dose button 56 such that the component does notrotate relative to housing 12 during dose delivery.

For purposes of illustration, magnet 152 is shown as a single, annular,bi-polar magnet attached to flange 38. However, alternativeconfigurations and locations of magnet 152 are contemplated. Forexample, the magnet may comprise multiple poles, such as alternatingnorth and south poles. In one embodiment the magnet comprises a numberof pole pairs equaling the number of discrete rotational, dose-settingpositions of flange 38. Magnet 152 may also comprise a number ofseparate magnet members. In addition, the magnet component may beattached to any portion of a member rotationally fixed to flange 38during dose delivery, such as skirt 42 or dose dial member 32.

Alternatively, the sensor system may be an inductive or capacitivesensor system. This kind of sensor system utilizes a sensed elementcomprising a metal band attached to the flange similar to the attachmentof the magnetic ring described herein. Sensor system further includesone or more sensing elements, such as the four, five, six or moreindependent antennas or armatures equi-angularly spaced along the distalwall of the module housing or pen housing. These antennas form antennapairs located 180 degrees or other degrees apart and provide aratio-metric measurement of the angular position of metal ringproportional to the dose delivered.

The metal band ring is shaped such that one or more distinct rotationalpositions of metal ring relative to the module may be detected. Metalband has a shape which generates a varying signal upon rotation of metalring relative to antennas. Antennas are operably connected withelectronics assembly such that the antennas function to detect positionsof metal ring relative to sensors, and therefore relative to housing 12of pen 10, during dose delivery. Metal band may be a single, cylindricalband attached to the exterior of the flange. However, alternateconfigurations and locations of the metal band are contemplated. Forexample, the metal band may comprise multiple discrete metal elements.In one embodiment the metal band comprises a number of elements equal tothe number of discrete rotational, dose-setting positions of flange. Themetal band in the alternative may be attached to any portion of acomponent rotationally fixed to flange 38 during dose delivery, such asdial member 32. The metal band may comprise a metal element attached tothe rotating member on the inside or the outside of the member, or itmay be incorporated into such member, as by metallic particlesincorporated in the component, or by over-molding the component with themetal band. MCU is operable to determine the position of the metal ringwith the sensors.

MCU is operable to determine the start position of magnet 152 byaveraging the number of sensing elements 160 (for example, four) at amaximum sampling rate according to standard quadrature differentialsignals calculation. During dose delivery mode, sampling at a targetedfrequency is performed by MCU to detect the number of revolutions ofmagnet 152. At end of dose delivery, MCU is operable to determine thefinal position of magnet 152 by averaging the number of sensing elements160 (for example, four) at a maximum sampling rate according to standardquadrature differential signals calculation. MCU is operable todetermine from calculation of the total rotational angle of travel fromthe determined start position, number of revolutions, and the finalposition. MCU is operable to determine the number of dose steps or unitsby dividing the total rotational angle of travel by a predeterminednumber (such as 10, 15, 18, 20, 24) that is correlated with the designof device and medication.

In one aspect, there is disclosed a modular form of the dose detectionsystem. The use of a removably attached module is particularly adaptedto use with a medication delivery device in which the actuator and thedose setting member both include portions external to the medicationdevice housing. These external portions allow for direct attachment ofthe sensing component to the actuator, such as a dose button, and asensed component to a dose setting member, such as a dose skirt, flange,or dial member, as described herein. In this regard, a “dose button” isused to refer more generally to a component of a medication deliverydevice which includes a portion located outside of the device housingand includes an exposed surface available for the user to use in orderto deliver a set dose. Similarly, a dose “skirt” refers more generallyto a component of a medication delivery device which is located outsideof the device housing and which thereby has an exposed portion availablefor the user to grasp and turn the component in order to set a dose. Asdisclosed herein, the dose skirt rotates relative to the dose buttonduring dose delivery. Also, the dose skirt may be rotationally fixed tothe dose button during dose setting, such that either the dose skirt ordose button may be rotated to set a dose. In an alternative embodiment,the delivery device may not include a dose skirt, and a user may graspand rotate the actuator (e.g., dose button) for dose setting. In someembodiments, with a dose detection module attached to the actuatorand/or the dose skirt, the dose detection module may be rotated tothereby rotate the dose setting member of the delivery device to set adose to be delivered.

It is a further feature of the present disclosure that the sensingsystem of dose detection system 80 may be originally incorporated into amedication delivery device as an integrated system rather than as anadd-on module.

The foregoing provides a discussion of various structures and methodsfor sensing the relative rotation of the dose setting member relative tothe actuator during dose delivery. In certain embodiments of medicationdelivery devices, the actuator moves in a spiral fashion relative to thepen body during dose setting. For illustrative purposes, this disclosuredescribes the dose detection system in respect to such a spiralingactuator. It will be appreciated by those skilled in the art, however,that the principles and physical operation of the disclosed dosedetection system may also be used in combination with an actuator thatrotates, but does not translate, during dose delivery. It will also beunderstood that the dose detection system is operable with otherconfigurations of medical delivery devices provided that the deviceincludes an actuator which rotates relative to a dose setting memberduring dose injection.

Detection systems may also be employed with the module for identifying acharacteristic of the medication to be administered by a pen injector.Pen injectors are used with a wide variety of medications, and even withvarious types of a given medication as already described. For example,insulin is available in different forms depending on the intendedpurpose. Insulin types include rapid-acting, short-acting,intermediate-acting and long-acting. In another respect, the type of themedication refers to which medication is involved, e.g., insulin versusa non-insulin medication, and/or to a concentration of a medication. Itis important not to confuse the type of medication as the consequencesmay have serious implications.

It is possible to correlate certain parameters based on the type of amedication. Using insulin as an example, there are known limitations asto the appropriate amount of a dose based on factors such as which typeof insulin is involved, how the type of insulin correlates to the timingof the dose, etc. In another respect, it is necessary to know which typeof medication was administered in order to accurately monitor andevaluate a treatment method. In one aspect, there is provided a sensorsystem which is capable of differentiating the type of medication thatis to be administered.

For determining the medication type, a module is provided which detectsa unique identification of the type of medication, such as, for example,any one of the medications described herein, contained in the medicationdelivery device. Upon mounting the module to the medication deliverydevice, e.g., pen injector, the module detects the type of medicationand stores it in memory. The module is thereafter able to evaluate amedication setting or delivery in view of the type of medication in thepen, as well as previous dosing history and other information. Oneexample of detecting the type of medication is described later withidentification sensor 680 in FIG. 29. Another example is described next.

This medication type detection is useful with a variety of sensorsystems which are operable to detect a predetermined angular position ofsensed elements relative to an alignment feature. These sensor systemsinclude those previously disclosed herein. It is a further aspect thatthis medication type determination is readily combined with sensorsystems for detecting the amount of a dose delivery. The two systems mayoperate independently or in concert with one another.

In a particular aspect, the sensor system used for detecting dosedelivery is also used to identify the medication type. For example,FIGS. 10A-10B and FIGS. 11A-11B and related text describe a magneticsensor system which includes sensing elements 160 and a magnet 152 todetermine the amount of a delivered dose. Magnet 152 has a uniqueconfiguration such that the sensor system is able to detect specificangular positions of magnet 152 relative to the sensing elements.

The illustrative sensor system 230 is also useful as a system which isintegrated into a medication delivery device, rather than being providedas a removable module. Referring to FIG. 12, there is shown a medicationdelivery device 310 substantially the same as device 10 in FIGS. 1-4.Medication delivery device 310 includes device body 11 and dose settingmember 30 comprising dose dial member 32, flange 38, and skirt 42. Thesecomponents are configured to function as previously described. Actuator50 comprises clutch 52 and dose button 56 attached thereto. Dose button56 is rotationally fixed with dose setting member 30 during dosesetting. For dose delivery, this rotational fixing is disengaged, anddose setting member 30 rotates relative to dose button 56 in proportionto the amount of dose delivered. Other embodiments of the dose detectionsystems described herein may be incorporated integrally into the device310.

FIGS. 13-15 depict another example of the module, now referenced asmodule 400, that is attachable to a medication delivery device havingthe dose button 402 including a cylindrical sidewall 404 and a top wall406 disposed coaxially about a device axis AA. Top wall 406 of dosebutton 402 includes an upper or proximal axial surface 408 which isdirectly pressed by a user to deliver a dose when module 400 is notmounted on dose button 402. Top wall 406 extends radially-outward ofside wall 404, thereby forming a lip 410. Sidewall 404 extends betweenthe upper surface 408 and a distal end as shown in FIG. 14.

Module 400 includes a housing 411 generally comprising a proximal wall412 and a distal wall 414. Module 400 further includes perimetricsidewall 416 extending between and forming a compartment 418 withproximal wall 412 and distal wall 414. When mounted to a dose button, adistally facing axial surface 413 of distal wall 414 is illustrativelyreceived against upper surface 408 of dose button 402. The walls ofmodule 400 are shown in a particular configuration, but the walls may beof any desired configuration suited to forming compartment 418. In oneexample, compartment 418 may be configured to resist entry of moistureand particulate matter. In another example, compartment 418 may beconfigured to resist dust and debris but not resist entry of moisturedirectly. Industry standards provide guidance for the differentstandards for moisture and dust protection.

Having similar components as module 82 in FIGS. 5-6, compartment 418 mayinclude a various desired components for use with the medicationdelivery device, as disclosed herein. Such components may include, forexample, measurement or other sensors, one or more batteries, MCU, aclock timer, memory, and a communications assembly. Compartment 418 mayalso include various switches for use as described hereafter.

Any of the modules described herein can be removably coupled to any ofthe dose buttons described herein via an attachment element 419 coupledto module housing 411. Attachment element 419 includes a plurality ofdistally extending arms 420. As shown generally in FIG. 13, module 400is attached to dose button 402 by arms 420 which are attached to andextend distally from housing 411. In an exemplary embodiment arms 420are equi-radially spaced around dose button 402. Arms 420 are depictedas being attached to distal wall 414 at attachment location 422.Alternatively, arms 420 may be attached to module 400 at otherlocations, such as at sidewall 416. Sidewall 416 may include a distalportion 424 disposed radially outward from arms 420 which extendsdistally from sidewall 416 a distance farther than the distalmostextension of arms 420 to at least partially or fully cover arms 420 toinhibit tampering or access to arms when mounted to device. Distalportion 424 may include an inwardly-extending portion 426 which furtherencloses arms 420. Alternatively, distal portion 424 may be provided asa member which is slidable relative to sidewall 416.

Arms 420 are configured to move over lip 410 of dose button 402 and toprovide frictional engagement with a radially outward facing surface 421of sidewall 404. Arms 420 include a first portion 428 extending axiallyand configured to extend beyond lip 410. Arms 420 further include abearing portion 430 extending radially-inward of first portion 428 andreceived against radially outward facing sidewall 404 of dose button402. Portions 428, 430 may be joined by a rounded base 429 coupledbetween them to form a “J” shape with the first portion 428 forming thestaff portion and the base and bearing forming the hook end. Bearingportion 430 may include an axially-bearing portion 432 received againstthe underside of lip 410. This provides added resistance to proximaldisplacement of module 400 relative to dose button 402. However, theengaged surfaces of the underside of lip 410 and axially-bearing portion432 may be provided with angled surfaces to facilitate removal of module400 when desired. In one example, each of arms 420 is radially movableto clear the lip 410 during attachment to and detachment from dosebutton. In one example, both portions 428, 430 flex outward, and in someexamples, only one of the first portion 428 or bearing portion 430flexes outward to move over lip. Arms 420 may be biased in a radiallyinward configuration and may be deflected or pivoted outward aboutattachment location 422. In the biased configuration, arms 420 areadapted and sized to apply radial normal force against a number ofengagement spots along the surface of sidewall 404 that is suitable foraxial retention to dose button 402, as well as torque transmission(without or little acceptable slip) during dose setting and/or dosedispensing.

An assembly 434 including arms 420 attached to distal wall 414 (shown asmolded or manufactured component) is shown in FIG. 15. For purposes offabrication, arms 420 and other components are combined with distal wall414 (shown as a radially outward surface of wall 414), which is thenattached to other parts of module 400. FIGS. 16-17 shows the distal wall414 and some of its component parts. Distal wall 414 includes anaperture 436 formed therein to allow an identification sensor, describedhereafter, to view the upper surface 408 of dose button 402. Light guideaperture 436 may have a variety of shapes, including the “D” shape asshown. Another opening 438 formed therein accommodates a presenceswitch, also described hereafter, to enable module 400 to determine whenit is mounted upon dose button 402. In one example, the opening 438 isomitted from distal wall 414. Sensor receiving recessed locations 440are provided in the distal wall for radially spaced placement of fourmeasurement sensors, e.g., magnetic, inductive, or capacitive sensingelements as previously disclosed. The depth of the recesses 440 is sizedto place the sensors in close proximity to the sensed component, whileleaving sufficient material thickness to structurally support thesensors during manufacturing and use. Recesses 440 allow for securefixing of the sensors so that the sensors maintain their respectivelocations for more consistent sensing capability. Recesses 440 arearranged to place the sensors are disposed equi-angularly (four sensorsat 90 degrees apart (as shown); five sensors at 72 degrees apart, sixsensors at 60 degrees apart, etc.) relative to one another andequi-radially disposed from the module longitudinal axis. Walls definingthe recesses 440 are also structured to disposed the sensors along acommon plane. Other ports may be provided for venting of the module.Attachment axial wings 441 may be provided for coupling distal wall 414to a complementary attachment feature of the module housing.

The number of arms 420 may vary, such as, for example, in the range of 3to 36, due to desired axial retention force and/or torque transmission.Arms 420 are depicted as being attached to distal wall 414 at attachmentlocation 422 defines by posts, which may be a single post or a pair ofposts 442, 444 as shown. Assembly 434 is shown including sixteen arms420. Assembly 434 is shown including four pairs of mounting posts 442,444 that are circumferentially spaced around the perimeter of distalwall 414. Each pair of mounting posts is configured to support acircumferential segment 445 having a plurality of arms, such as fourarms each. Each segment 445 includes mounting holes 446 which receivethe mounting posts 442, 444. Once received in position, the mountingposts 442, 444 are used to heat stake the arm segments to distal wall414 in a securely fixed manner.

The attachment of the arms 420 to the housing allows for fabrication ofthe arms from a variety of materials. These materials may be selected toobtain desired features of strength, elasticity, durability and thelike. For example, it has been found that beryllium copper hasadvantageous properties for use as the arms. The separate attachmentalso provides flexibility as to the placement of the arms relative tothe dose button. For example, the arms may be mounted to various wallsof the module, including distal wall 414, sidewall 416, or distalportion 424.

Arms 420 may be suitable for different configurations of surface 421 ofdose button 402. FIG. 14 illustrates the surface 421 have a smooth(without ribs or grooves or planar variations). The surface 421 ofbutton may include surface features to enhance torque transmission witharms 420. Other embodiments may be used for the interaction between thearms and the perimetric wall of the dose button. FIG. 18, for example,shows another example of a dose button 470 for a device including asidewall 472 having spaced, axially-extending ridges 474, forming aseries of recesses 476 therebetween. In this embodiment, portions ofarms 420 can be receivable within recesses 476. Arms 420 may be suitablefor another configuration of ridges shown in FIG. 22. Thecircumferential width of recesses 476 may be sized to receive thecircumferential width of arms 420. The sizing may allow for a snug fitor may allow some circumferential freedom of arm movement. The presenceof the adjoining ridges provides further assurance that the module willnot rotate relative to the dose button during use. FIG. 19 shows analternate design in which dose button 480 includes a sidewall 482provided in a polygonal shape, thereby defining a series of flatsurfaces 484 for reception of the arms of the module. Separatingadjacent flat surfaces 484 is a rounded axial joint 485. The use of aflat, smooth cylindrical surface avoids any issues regarding orientationof the module relative to the dose button, while the recessed andpolygonal designs provide additional frictional engagement of the armswith the sidewall of the dose button.

FIGS. 20-24 illustrate another example of a module attachmentsubassembly, now referenced as unit 500, configured, when part of amodule, to be removably coupled to any of the dose buttons describedherein via an attachment element 519. Attachment element 519 is coupledto a tubular attachment housing 511 (although other parts of the modulehousing are omitted, aspects of these parts to define a full modulehousing are shown in FIG. 13 and FIG. 25). Attachment housing 511 withthe attachment element 519 may form a part of the module 600 as will bedescribed later. Attachment element 519 includes a plurality of distallyextending arms 520. As shown generally in FIG. 20, unit 500 when part ofa module is attached to another example of dose button 502 by arms 520which are attached to and extend distally from housing 511, and inparticular distally from annular housing portion 517 of housing 511 atrecessed areas defined by the distal wall 514. The annular housingdefines a cavity to receive for example at least partially electronics.In an exemplary embodiment arms 520 are equi-radially spaced around dosebutton 502. Arms 520 are depicted as being coupled to and depending froma distal wall 514 of attachment housing 511.

FIG. 21 depicts arms 520 being resiliently configured to move over lip510 of dose button 502 and to provide frictional engagement with aradially outward facing surface 521 of sidewall 504 of dose button 502.With additional reference to FIG. 23, arms 520 include a bearing portion530 extending radially-inward of the axial body of arms 520 and receivedagainst radially outward facing sidewall 504. Bearing portion 530 mayinclude a protruding body 531 extending radially inward from theinterior surface of arm 520. Protruding body 531 may include anaxially-bearing surface 532 to be received against or place in closeproximity to the underside 533 of lip 510 shown in FIG. 24. Thisprovides added resistance to proximal displacement of the modulerelative to dose button 502 when attached. Protruding body 531 ofbearing portion 530 may include a distal facing end 537. The surface 532and/or distal facing end 537 may be angled at any angle to give theprotruding body 531 a tapered profile. Protruding body 531 may include aradially facing engagement surface 538 having an axial length extendingbetween surface 532 and end 537. Engagement surface 538 may by planar,rounded (as shown), tapered or V-shaped. As shown in FIG. 23, protrudingbody 531 may have a smaller width than the width of the arm 520. Inanother example, the arms may include more than one protruding bodyarranged to fit within adjacent ridges or alternating ridges.

FIG. 22 depicts the sidewall 504 of dose button 502 includes a pluralityof spaced, axially-extending ridges 545, forming a series of recesses547 therebetween. Button 502 also includes a proximal wall with aproximal upper surface 508. At least a portion of the proximal surface508 may have a color to correspond to a unique kind of medication and/ordosage. The button 502 with color is representative of all the otherbuttons described herein as those other buttons may have similar colorschemes. To this end, any of the modules described herein can beattached to different kinds of pens, and with the use of color detectionthe module can communicate the identification information to an externaldevice. The module and/or external device may determine a differentnumber of units of medication delivered for the same amount of totalrotation due to the pen having a unique rotational profile for a givenmedication and dosage. In one example, the entire upper surface 508 ofthe button 502 is a single color. In another example, a surface featureor region 507A, such as recess or a protrusion or the center of thebutton surface, may have a first color, and a region 507B adjacent tothe surface feature or specific region may have a second color differentthan the first color. The medication identification sensing describedherein may be directed to the first color or the second color dependingthe module's configuration. In this embodiment, at least a portion ofthe bearing portion 530 of arms 520 are receivable within recesses 547.In one example, the circumferential width of each of the recesses 547may be sized to receive the circumferential width of engagement surface538 of bearing portion 530, and in other embodiments, recesses 547 maybe sized to receive a tip end portion of the engagement surface of anyof the tips of the arms described herein, such, as, for example, asshown in FIG. 20. The circumferential width of each bearing portion 530may be oversized to fit over the recesses 547, engaging adjacent ridgeswithout going into the recesses. In one embodiment, the proximal extent549 of the recesses 547 may extend within the radial lip 510. The depthD1 of the recesses 547, shown in FIG. 24, may be constant along theaxial extent of the recess. In other examples, the depth of the recesses547 may vary along the axial extent, such as, for example being sized tobe deeper toward the proximal end than toward the distal end of recess547. Arms 520 may also suitable for other button surfaces, such as, forexample, shown in FIGS. 14, 18, and 19. The overhang axial distance O ofaxially-bearing surface 532 of arms 520 relative to the distally facingaxial surface 513 of distal wall 514 may be larger than the axial depthD of the radial lip 502.

With reference to FIG. 24 the amount of extension length of the arms520, beyond a plane defined by the distally facing axial surface 505 ofdistal wall 506 and orthogonal to the axis AA, may be sized to place thebearing portion 530 along the radially outward facing surface 521 ofsidewall 504 of dose button 502. In one example, extension length issized to place the bearing portion 530 along only a proximal upperportion 509 of the sidewall 504 such that a distal lower portion of thesidewall 504 remains unengaged by any portion of the arms. The dosebutton shown in FIG. 24 includes an axial height H measured between theupper surface 508 of the dose button 502 and the distal end 511 of thedose button 502. The distal end 513 of the bearing portion 530, that is,the distalmost part of the bearing portion 530 that is in directengagement with the sidewall 504, of arms 520 engages the surface 521 ofsidewall 504 at an axial distance HL, thereby placing the surfaceengagement portion 538 of bearing portion 530 between the radial lip 510and the engagement location of distal end 513 against the sidewall. Thebearing portion may axially extend between the underside of the rim 510and the engagement location of the distal end 513 that is located alongthe upper half of the sidewall 504. Axial distance HL is measuredbetween said plane defined by the surface 505 that is against the uppersurface 508 of dose button 502 and such engagement location of thedistal end 513, as shown in FIG. 24. In one example, the axial distanceHL may be sized up to 50% of the axial height H of the dose button 502to place the bearing portion 530 along the proximal portion 509 ofsidewall 504. This position may reduce the spatial impact of the armswithin the attached module placed the button. Engagement surface 538 ofthe bearing portion 530 is sized axially larger than the axial thicknessof the radial lip 510 for greater radial force. The bearing portion 530of the arms 520 in a more axially compact configuration as shown mayreduce the amount of axial travel and friction causing forces of surface538 of the bearing portion along the rim 510, and thereby reducing theattachment and/or detachment force for the user. A more axially compactbearing portion of the arms may also reduce the amount of duration forattachment and/or detachment of the module so that user is not leftdoubting whether attachment was successful.

FIG. 21 illustrates each of arms 520 is radially movable in a directionof arrow 535 to clear the lip 510 during attachment to (or moving modulein a proximal direction P relative to the dose button) and detachmentfrom dose button (or moving module in a distal direction DD relative tothe dose button). Arms 520 may be biased in a radially inwardconfiguration and may be deflected or pivoted outward about where thearms depend from the distal wall 514. In the biased configuration, arms520 are adapted and sized to apply radial normal force against a numberof engagement spots along the surface of sidewall 504 that is suitablefor axial retention to dose button 502, as well as torque transmission(without or with little acceptable slip) during dose setting and/or dosedispensing. In other words, during dose setting the unit 500 that iscoupled to button 502 is rotated in a first direction that moves themodule/button farther away from the device housing.

With any of the attachment elements described herein, such as elements419 and 519, the attachment force that the user applies in the distaldirection DD may be less than the detachment force that the user appliesin the proximal direction P. The detachment force may be in the range of4 N to 30 N. In one example, the arms are configured such that thedetachment force is at least 1.5 times the attachment force, and may beat least twice as large as the attachment force to inhibit inadvertentdetachment of the module. In one example, the detachment force is over20 N and the attachment force is under 11 N. In other examples, once themodule is attached to the device, a small degree of slippage of thebearing portions along the dose button due to torqueing from dosesetting may be permissible in order to avoid over-torqueing andpotential damage to the dose setting device components.

The arms 520 and housing 511 may be formed as an integral unit, such aswith molding of a plastic material, such as an acetal thermoplastic (forexample, Delrin®), or polycarbonate material (for example, Makrolon®).Such an integral unit 561 is shown in FIG. 23. The plastic materials maybe selected to obtain desired features of strength, elasticity,durability and the like. Alternatively, the arms 520 may be separatelymade from the housing and later attached via an adhesive or welding. Thenumber of arms 520 may vary. In the example shown, there are four armspositioned circumferentially spaced equally apart. In some examples,three arms may be provided, in other examples, 5, 6, 7, or 8 arms may beprovided.

The arms described herein, such as arms 420 or 520, provide a convenientand effective attachment of the module to the dose button. As the moduleis intended for use on multiple medication delivery devices, the moduleattachment allows for ready attachment and removal of the modulerelative to the dose button. This derives from the arms described hereinhaving suitable configurations and physical properties to set the amountof force required to attach/detach the module. The arms described hereinare also configured to have sufficient durability for repeatedattachments to medication delivery devices, and to retain elasticity toprovide proper securement and retention to the button without the use ofa separate retainer piece, such as a coiled spring or ring, disposedalong the outside to provide radially compressive force.

Once mounted to a medication delivery device such as, for example, withthe use of any one of the attachment elements 419 or 519, the module isfrictionally engaged with the dose button. This allows for use of themodule to rotate the dose button as desired, such as during dose settingfor some medication delivery devices. The surface engagement of thebearing portions of the arms described herein may be controlled throughvarious parameters. Frictional engagement depends on such factors as theforce applied normal to the module surface and the coefficient offriction applicable for the contacting surfaces. The applied radialforce is dependent, inter alia, on the sizes and shapes of the arms, theelasticity and resilience of the arms, and other factors. The disclosedattachment elements allow for selection among these and other parametersin order to provide the desired balance to frictionally lock the modulewith the dose button for rotation, and to allow for ready attachment anddetachment of the module relative to the dose button.

Any of the modules described herein may include one or more switches tofacilitate use of the module, even though the following description isrelated to the module 600. As previously described, the module isreleasably attached to a medication delivery device. When desired, themodule is removed from one medication delivery device and then is usefulin conjunction with another medication delivery device. One skilled inthe art would appreciate that various attachment elements describedherein may be used for such coupling to the device. Referring to FIGS.25-28, the module 600 includes a proximal wall assembly 602, sidewall604 and distal wall 606. Walls 602, 604, 606 of module 600 therebydefines an internal compartment 608 configured to house an electronicsassembly 610. Wall 602 may include a transparent or translucent materialaround the upper edge to provide a light guide when LEDs are employed.

Although the attachment element 607 is illustratively shown as theattachment element 419 in FIG. 15, it should not be limiting as module600 can also be provided with any other attachment unit describedherein. In such configuration, proximal end opening of the tubularattachment housing 511 is sized to fit over the circumferential outersurface 609 of distal wall 606 with a friction fit or otherwise securelyfixed. In this configuration, distal wall 606 is illustratively shown inFIGS. 16-17 as the distal wall 414 (with the feature such as, forexample, openings 438, 436 and features 440, 441), with the exception ofthe posts 442, 444 and block protrusion disposed between the posts 442,444 are omitted, thereby providing a smooth outer surface 606A of distalwall 606 that is sized and shaped to receive the unit 500.

FIGS. 25, 26, 27 and 29 show an example of electronics assembly 610 thatmay be used for any of the modules described herein. Assembly 610includes a first distal segment 612, a second proximal segment 614, anda third intermediate segment 616 therebetween, each havingelectronically connected by connections and leads, shown generally at618A-B. Segments 612, 614, 616 may be coupled coaxially disposed overone another in an “S” pattern. Battery 621 is shown axially disposedbetween the first and third segments 612, 616 and captured by resilientarms. The second segment 614 may include sensor pockets 623 definedtherein for receiving the measurement sensors, such as, for example,sensing elements 160. Pockets 623 are aligned and inserted withinrecessed locations 440 of distal wall of module housing. Alternatively,instead of pockets 623, the measurement sensors may be coupled directlyto the second segment circuit without the pockets.

In FIG. 27, the first segment 612 includes a proximal facing surface 615and includes an example of a switch 622 of a wake-up switch system 620mounted thereon. Module may include indicator elements 624, such as LEDsfor indication of operator status of device and/or module. In oneexample, the indicator elements 624 are operably mounted to surface 615of first segment 612. Activation of wake-up switch 622 may be used toturn on relevant electronics, such as those associated with the deliveryof a dose. For example, wake-up switch 622 may turn on the measurementsensor, such as, for example, the sensing elements 160, involved in themeasurement of a dose delivery generated by rotation of the sensedelement. LEDs or other indicator elements, such as, audible speakersand/or vibration generators, may be used to notify the user of theprogression of the system through completion of the dose delivery ornotify the user between periods of dose delivery, such as, for example,battery charge indication. In one example, LEDs are mounted on the sidesof the switch 622. Wake-up switch system may be configured to increasethe power to the electronics from a low power state to a full operationstate.

Any of the module described herein may include a wake-up switch system620. The provision of such wake-up switch with a module may be optional.In one example, the module 600 shown in FIGS. 25-26 includes the wake-upswitch system 620 which includes an axially movable segment 626 disposedwithin a recess defined in the upper surface of the proximal wallassembly 602. Wake-up segment 626 is able to move distally into module600, and has a biased configuration as shown. Wake-up segment 626 mayfor example comprise a flexible disc-shaped member which is normally ina proximal position, or it may be a member that is biased proximallysuch as by springs (not shown). The material of the wake-up segment mayallow for some deflection of the center 627 of the segment 626 relativeto the circumferential edge 629 of the segment 626. Segment 626 may be arigid member slidably disposed along walls defining a recess within theproximal portion 602 of the module housing. Segment 626 may include ananchoring segment (not shown) movably coupled to the module housing suchthat that when segment 626 is in its biased proximal position, segmentremains within module housing without exiting the module. Walls 630 ofproximal wall assembly 602 may be shaped to define a proximally facingaxial surface 631 configured to define a physical stop or its distalmostposition for the distal travel of the segment 626 from its biasedproximal position. Walls 630 define a smaller sized portion of thethroughbore 632 extending axially along the axis AA through the proximalwall 602.

When user distally actuates the wake-up segment 626, the axial force issufficient to overcome the biasing force of the spring (not shown) andallow distal movement of the segment 626 until directly or indirectlycausing activation of the switch system 620. This axial force to actuatewake-up is less than the axial force to cause actuation of the deliverydevice for dose delivery. In one example, segment 626 may be distallymoved to engage the axial surface 631, while the walls 630 defining thethroughbore 632 may be sized and shaped to allow continued axialdeflection of segment 626 distally beyond the axial surface 630 suchthat there is sufficient to activate the switch system 620. The switchshown includes a mechanical switch or rubber dome switch, while otherswitches are contemplated such as electrical contacts. Switchesdescribed herein can be mechanically actuated or triggered by engagementwith another component.

In one example, switch system 620 may further include a flexible shroud635 configured to limit the travel of distal deflection of segment 626when pressed by user to inhibit damage to the wake-up switch 620. Shroud635 may be axially located between the segment 626 and the switch 622.Axial force from the user may be transmitted via the segment 626 toshroud 635 to cause central portion 638 of shroud 635 to axially deflectto engage the trigger of the switch 622. Shroud 635 may be configured tohave a maximum distal extent of deflection. Such distal extent may besized to allow engagement of the switch trigger but not farther to aposition that may damage the switch. Shroud may have various sizes andshapes for such functionality.

FIG. 28 illustrates one example of shroud 635, including a plurality ofradial legs 640 circumferentially disposed relative to one another,extending from a centerpoint of a hub 642 that surrounds central portion638 of shroud. Centerpoint of hub is located coaxially with the axis AA.The hub 642 and central portion 638 may have any shape, and may berectangular, oval, or circular as shown. The central portion 642 mayinclude a concaved region that extends the hub in the distal directionrelative to the surrounding hub region radially outside the concavedregion. The end tips 643 of a first set of legs 640A may be coupled toanchor portions 644, such as for example the distal surface of anchorportions 644 having a slotted region sized and shaped to receive thesize and shape of the tips 643. Anchor portion 644 extend distally fromaxially movable segment 626, which place the anchor portions 644 on topof the tips 643. Anchor portions 644 moves axially with segment 626within throughbore 632 when user applies axial force thereto. Anchorportions 644 may be integrally formed with the segment 626 such as frommolding or portions 644 may be formed separately and fixedly secured tothe distal surface of segment 626. The tips 646 of a second set of legs640B may be free or remain unengaged with the segment 626. The first setof legs 640A may be contacted by anchor portions 644 at equi-angularlylocations to distribute the axial force and deflection to each of thelegs 640. In one example, the first set of legs 640A are shorter inradial length than the longer second set of legs 640B. The first set oflegs 640A may radially extend directly in between adjacent legs of thesecond set 640B. While all of the legs 640 may provide flexibility tothe shroud 635, the free legs 640B can inhibit the shroud 636 to havethe maximum distal extent of deflection while force is axiallytransmitted from segment 626 to the tips 643 via the anchor portions 644to move the tips 643 within the throughbore 632. In the example shown,there are eight total legs 640 each disposed radially from thecenterpoint by 45 degrees apart. The shorter fixed legs may be disposed90 degrees apart, and the longer legs may be disposed 90 degrees apartand radially offset relative to the shorter fixed legs. Other numbers oflegs and their relative positions may be used. In one example, theelectronic assembly 610 is powered on from a sleep state by axialmovement of segment 626 and shroud 635 caused by a user to a degree tocontact the axial trigger of switch 622, such as, for example, withoutany distal movement of the module and/or dose button. In thealternative, the wake-up switch may include one or more leaf springelectrical contact elements that are biased away from contact withcorresponding contact pads mounted on the first segment, and are movablefor contacting the contact pads from force transmission via the member626. In some examples, power on of electronic assembly occurs bysimultaneous contact of each of the contact elements.

Any of the module described herein may include a presence switch system650. The provision of such presence switch with a module may beoptional. According to FIGS. 25, 26 and 27, module 600 includes presenceswitch system 650 mounted to distal wall 606 in a manner to detect whenmodule 600 has been mounted to or removed from a medication deliverydevice. A presences switch 652 of system 650 is operably connected tothe proximal face 617 of the second segment 614 of electronics assembly610. Switch 652 includes a pivot switch arm 654 positioned at leastpartially overlapping the opening 657 (see opening 438 in FIG. 16)defined by distal wall 606. Distal wall 606 may include the same layout(or substantially the same layout) of features, such as, for example,openings 438, 436 and features 440, 441, shown in FIG. 16-17. Switch arm654 of switch 652 has a biased position (shown in FIG. 27) and a distalposition (shown in dashed lines). As represented in FIG. 25-26, switchsystem is movable from its biased distal position (as shown in FIG. 26)representing the absence of a medication device, to a proximal position(shown in FIG. 25) indicating that module 600 is mounted to a medicationdelivery device.

Presence switch system 650 includes a switch actuator 660 that ismounted to distal wall 606. Actuator 660 includes a first member 662 ina nesting relationship with a second member 664. The second member 664has a cup configuration defining a cylindrical cavity to receive thefirst member 662. The second member 664 is slidably disposed throughopening 657. The second member 664 includes an outer radial lip 663along its proximal end and housed within module to enhance theinhibition of particulates and/or water ingress. Though the radial lip663 is shown in FIG. 25 disposed away from distal wall, the radial lip663 may remain engaged with the distal wall, such as shown in FIG. 26,when the module is attached to the device. The second member 664 may bemade of elastomer or soft plastic material for flexibility. Secondmember 664 is movable within the module housing to a proximal positionby direct engagement with the device when mounting the module to thedevice. First member 662 is shaped and sized to fit within the cavitydefined by the second member 664. First member 662 includes acylindrical body 666 extending axially between its proximal and distalaxial ends. An outer radial rim 668 is shown extending from anintermediate segment of the first member body 666 such that a distal hatsegment 670 is defined for insertion into a distal end of an actuatorspring 672. The actuator spring 672 is fixedly secured at its proximalend to an internal component of the module housing, and the actuatorspring's distal end is bearing on the rim 668 and movable therewith. Rim668 may include a distal skirt 674 depending from the distal surface ofthe rim 668. In one example, the distal skirt 674 is coupled to theouter radial end of the rim. The rim 668 may comprise of diametricallydisposed radial elements instead of a continuous circumferentiallyelement.

Under the biasing force of the actuator spring 672, the first member 662is in a nested position within the second member 664 and the rim 668 ofthe first member 662 is configured to contact and distally move theswitch arm 654 to place the system at its biased distal position whenthe module is removed from the device. Switch system 650 in its distalposition indicates electronically the module is not mounted to a device,and power limitations may be programmed into the processor to performminimal functions. Skirt 674 may provide radial pressure along the lip663 of the second member against the interior surface of distal wall 606to enhance inhibition of particular ingress. Upon coupling the module tothe device, the exterior end of the second member 664 with the firstmember 662 is in a nested position contacts the dose button of thedevice and force is transmitted to the rim via the body of the firstmember to overcome the force of spring 672, thereby causing the firstand second members to move proximally within the module housing andthereby allowing the switch system to return to the proximal position.Switch system 650 in its proximal position indicates electronically themodule is mounted to a device, and full power may be programmed into theprocessor to perform all functions.

Actuator 660 is biased in the distal direction by spring 672, andnormally extends distally out of opening 657 when module 600 is notmounted to a medication delivery device. As shown somewhatdiagrammatically in FIG. 25, mounting module 600 to any one of the dosebuttons described herein, generally 601, causes the upper surface ofdose button 601 to press actuator 660 proximally, and this movement inturn moves switch arm proximally, triggering presence switch 652. MCU ofelectronic assembly 610 recognizes the proximal position of switch arm654 as a confirmation that unit 500 is mounted to a medication deliverydevice. In response, MCU wakes up or provides power to relevantcomponents of electronics assembly 610 in preparation for use of themedication delivery device. When module 600 is subsequently removed,spring 672 moves actuator 660 back outside of distal wall 606 and switcharm 654 returns to its distal position identifying that module 600 isnot mounted to a medication delivery device. MCU then returns themedication delivery device to a non-use state, such as by turning themodule systems off or setting them in a sleep mode. One example ofelectronic assembly 610 is shown schematically in FIG. 46.

Illustratively, any of the modules described herein, such as module 600,may also include a sensor for identifying the type of medicationdelivery device, or the type of medication contained by the medicationdelivery device. Referring to FIG. 29, the identification sensor 680 isoperably connected to the distal face 617 of the third segment 616 ofthe electronic assembly 610. The second segment 614 includes a windowopening 682 defined therein. Identification sensor 680 is located overwindow opening 682 and aperture 684 of distal wall 606 (see apertureconfiguration and layout in aperture 436 in FIGS. 16-17) to be able toview the exposed surface of dose button 601. A recess 686 may be formedalong the distal face of the distal wall 606 that overlaps the aperture684. The recess 686 may receive a coupled lens or shield therein to aidin keeping debris out. Dose button 601 is provided with indicia visibleto type sensor 680 through aperture 684. The indicia correlate toinformation concerning the medication delivery device, such as the typeof device or the medication contained by the device. Identificationsensor 680 reads the indicia and MCU recognizes the indicia asindicating the medication delivery device information. A light guidemember 685 may be disposed within the aperture 684 to provide an opticalpath for the identification sensor. Securing light guide member 685 todistal wall 606, such as, by snap fit or adhesive or ultrasonic welding,can prevent light and sensing distortion caused by relative movement orvibration of the light guide member. Light guide member 685, which couldbe made from a transparent or translucent material, such as, forexample, a polycarbonate, is shown extending axially between the uppersurface of the button 601 and the opening 682. Recess 686 may be also beconfigured to receive an enlarged base portion of the light guide member685.

By way of example, identification sensor 680 may comprise an RGBsource(s) and sensor to detect color reflected from the dose button andthe indicia may comprise different colors, each color being associatedwith specific information regarding the medication delivery device.Shielding elements may be provided to guide RGB light sources axially tobutton and to inhibit premature reading of light form sensor.Alternatively, the indicia may comprise grey scale, patterns, or othermaterial that is optically recognizable. In addition, more than one typesensor may be employed to enhance the detection of information regardingthe medication delivery device. In one embodiment, identification sensor680, is positioned to detect the near-center or center of the proximalupper surface of dose button 601. The indicia may at the same timecomprise patterns symmetrically positioned around the center of dosebutton 601, such as concentric color rings. With type sensor 680 solocated, presence switch 652 is positioned displaced from the center ofmodule 600.

In use, identification sensor 680 is activated with module 600 mountedto a medication delivery device. In one example, presence switch 652detects the mounting of unit 500 on a medication delivery device andidentification sensor 680 is activated at that time. Whenever collected,the sensed information concerning the medication delivery device may bestored and/or transmitted. Module 600 may then be moved to a lower powermode, such as after a predetermined time period, until reactivatedduring dose delivery.

As shown diagrammatically in FIG. 27, light indicator elements 624(shown as LEDs), or other signaling devices, may notify the user of thevarious states of module 600, as well as other components including themedication delivery device itself. For example, a light signal may beused to indicate the type of medication delivery device or themedication contained by the medication delivery device. Another signalmay be provided to confirm the proper placement of the module on themedication delivery device. Further, a signal may indicate thetransition of module 600 to or from various states, such as waking up orsleeping conditions. Indicator elements may be operable to indicate inone form (such as green) successful attachment or in another form (suchas amber) unsuccessful attachment between the module and the dose buttonof the device.

Assembling of the module may be configured in consideration of highvolume manufacturing. The following steps may apply to any of themodules described herein, with general reference to FIGS. 25 and 27, andin alternative sequential order than what is described below. The distalwall 606 as a component is provided in the orientation and arrangementshown in FIG. 16. The switch actuator 660 with the first and secondelements is inserted through opening 657 with the rim 668 of the firstelement sized to fit within the axial slots formed by upstanding wallssurrounding and extending from the edge of opening (as shown in FIG.16). Actuator spring 672 is placed on top of the actuator as shown inFIG. 25. The second segment 614 is placed with the interior of thedistal wall component in alignment around the various features andopenings formed along the distal component. An axial spacer component675 (shown in FIG. 25) is placed over top of the second segment 614 andthe distal wall. Spacer 675 includes alignment features to position thesegments at a predetermined relative distance. The segments are thenfolded over along connection 618A in order to place the third segment616 proximally on top of the spacer 675. Battery 621 is disposed on topof the third segment 616 and configured to operably provide power to allof the segments. The first segment 612 is then folded over alongconnection 618B in order to place the first segment 612 proximally ontop of the battery 621. Attachment elements are then coupled to distalwall 606, either sliding over the distal wall 606 with the unit 500 witharms 520 with the bearing portion as described previously or attachmentwith the arms of the attachment element 419 as described previously.Proximal wall portion component 602 is positioned over the first segment612 and includes attachment features for securely attaching to thedistal wall 606 including attachment to the attachment axial wings shownin FIG. 16 to form a preassembly. Proximal wall portion 602 may includethe axially movable segment 626 and the shroud 635 assembled together asdescried herein prior to attachment to the sidewall 604. Tubularconfigured sidewall component 604 is slidably placed radiallysurrounding the preassembly and its proximal end fixedly secured to theproximal wall portion 606. Distal skirt portion 677 is fixedly securedto the distal end of the sidewall 604 to thereby form a completelyassembled module.

Referring to FIG. 35, another embodiment of the module, now referred toas module 800, includes the proximal wall 802, sidewall 804 and distalwall 806. Walls 802, 804, 806 of module 800 thereby defines an internalcompartment 808 configured to house the electronics assembly 810.Proximal wall 802 may have a disk shape and form the finger pad thatuser presses for device operation. Module may include a ring 812 oftransparent or translucent material around the upper edge to provide aradial light guide when a light source, such as, for example, LEDs, isemployed, such as shown in FIG. 27. Such light source may be located onthe proximal surface of a circuit board 809 of the assembly 810 and ispositioned to emit light through the opening 813 defined by the lightguide ring 812. Confronting surfaces of the ring 812 and proximal wall802, respectively, may be securely fixed to one another to define theproximal wall assembly of the module housing. In one example, the secureattachment may be by an adhesive, gluing, ultrasonic welding, or thelike. In another example, the secure attachment may be a two-sidedsticky tape 860. The proximal wall assembly may include a white surfaceor reflective surface disposed covering the opening 813 for improvedradial light transmissivity within the light ring 812 that is emittedthrough the opening 813. The distal surface of the proximal wall mayinclude the white or reflective surface. In one example, the distalsurface 862 of the tape 860 includes the white or reflective surface,and in other examples a disk element with a white or reflective surfacemay be used. The proximal wall assembly described herein may only referto the proximal wall without the light ring. Ring 812 may include anattachment element to attach to another module component. For example,ring 812 may include a plurality of retention snap arms 812A dependingfrom a distal surface of ring 812. Arms 812A are configured to permitaxial movement of the proximal wall relative to the housing andincluding tips configured to prevent removal of the ring 812 to acertain position. A button gasket 811 having a ring shape is shownengaging the distal surface of ring 812 and is disposed radially outwardrelative to the arms 812A. FIG. 47 depicts an exploded view of oneembodiment of the module, such as module 800, separated into itsindividual components along a common axis.

Module may include a first spacer element 815 having a ring shape anddefining an inner radial surface 817 disposed along the circumferencedefined by the snap arms 812A. Surface 817 configured to allowcontrolled axial movement of the proximal wall assembly from theproximal position to the distal position for wake-up capability. Thedistal surface of spacer element 815 along the inner radial surface 817provides an area for the snap arms 812A to engage for retention as theproximal wall assembly returns to the proximal positon under the biasingforce. In some embodiments, the light ring is omitted and the proximalwall includes the snap arms for engagement with the surface 817. Spacerelement 815 may include a proximal flange 819A disposed along the radialoutward extent of the spacer element. The upper end of flange 819A canprovide a physical stop to limit distal movement of the proximal wall802. Spacer element 815 may include a distal flange 819B disposed alongthe radial outward extend of the spacer element and recessed radiallyinward relative to the proximal flange 819A. The recess may be sized toaccommodate the thickness of sidewall 804 when the upper end of thesidewall engages the radial outer surface of the distal flange 819B.

Button gasket 811 is disposed axially between the proximal wall 802 andring 812 and a housing portion in the form of the spacer element 815. Inone example, the button gasket 811 is engaged between ring 812, or theproximal wall if there is no ring, and element 815. Gasket 811 isaxially compressible from its natural state. The gasket material, suchas for example, a cellular urethane form, may be configured to providecompressibility. The material of gasket 811 may also provide sealingfrom liquid egress, but allowing the ventilation. In other embodiments,the gasket material may provide sealing from liquid and air egress. Inits natural state, the gasket 811 may provide a biasing force andsupport along the outer circumference of the proximal wall assembly tomaintain the proximal wall assembly in its extended proximal position.When a user presses down on the proximal wall to use the device, thebutton gasket 811 may axially compress as the ring/proximal wall unitmoves distally relative to the spacer element 815 that is in a fixedposition. The gasket 811 may aid in returning the proximal wall assemblyto the extended position and provide consistent tactile feedback to theuser throughout its movement. Instead of the compressible gasket, aspring with lining or other sealing means may be used.

Module may include a second spacer element 821 disposed distal to thefirst spacer element 815 in between the element 815 and distal wall 806.Second spacer element 821 has a ring shape. The second spacer element821 is coupled to the first spacer element 815, such as, for example,each having axially extending features that allow for coupling. Battery861 is shown disposed between elements 815, 821. A battery retainerelement (not shown) can be coupled to the proximal surface of the secondspace element. A battery support element 864 may be included between theproximal side of the battery and one of the circuit boards of theelectronics assembly, and in frictional contact with the battery toinhibit movement of the battery within the module. In one example, thebattery support element 864 may include a ring of axially compressiblematerial, such as, closed cell foam. The element 864 may have across-sectional area less than the battery's cross-sectional area.Sidewall 804 is shown disposed radially outward relative to the contentsof the module and axially extended between the first spacer element 815and a base ring 823 that is coupled to the distal end of the sidewall804. Base ring 823 may be optional. Sidewall 804 may include a pluralityof distally extending retention snap arms 804A for engaging withcorrespondingly shaped recesses formed along the interior surface of thebase ring 823 in a manner to securely fix the components together. Snaparms 804A may be disposed radially inward from the general outercircumference of the sidewall 804 to define a recess sized to receivethe general thickness of the upper end of the base ring 823. A seat 804Bmay be formed along the interior surface of the sidewall 804, extendingfarther radially inward of the surface. Seat 804B is configured toreceive a distal gasket 825.

Distal gasket 825 has a ring shape and is disposed radially between theinterior surface of sidewall 804 and the outer circumference of thedistal wall 802, and axially between seat 804B and a seat 827A definedby a radial flange 827 extending from the distal wall 802. In oneexample, gasket 825 is sealably engaged between sidewall 804 and distalwall 802. Gasket 825 may be made from a gasket material, such as forexample, a cellular urethane form, may be configured to providecompressibility.

Although the module 800 is shown with the presence switch omitted, apresence switch system, such as, for example, the system 650 describedearlier may be incorporated into the module as can be appreciated bythose skilled in the art.

Module 800 is shown including another embodiment of a wake-up switchsystem, now referred to as wake-up switch system 820. Although wake-upswitch system 820 is illustratively shown, it should not be limiting asmodule 800 can also be provided with the wake-up switch system 620.Similarly, the other modules described herein may include wake-up switchsystem 820.

With additional reference to FIG. 36, wake-up switch system 820 includesone or axially moveable contact arms 822 and a corresponding contact pad824 coupled to the circuit board 809, which can be the flexible printedcircuit board (FPCB), of the electronics assembly 810 and in electricalcommunication with the MCU. Contact arm 822 is able to move distallyfrom a biased, non-contact natural configuration, as shown in thefigures, where the contact arm 822 is axially spaced from the contactpad 824 such that there is no electrical communication (thus electronicsin a low power state) to a contact configuration by which the contactarm 822 and contact pad 824 are in a contacting relationship such thatthere is electrical communication between the two (thus increasing powerto electronics to the full operation state). Contact arm 822 may have apre-load to maintain contact with the proximal wall 802 along differentaxial positions of the movable proximal wall. The biasing may beprovided by a discrete spring or the contact arm 822 may have a leafspring configuration, such as shown.

In one embodiment, the contact arm 822 includes a base 830 fixedlymounted to the circuit board 809, a movable arm length portion 832coupled to the base 830 via a joint 834. The arm length portion 832 iscapable of pivoting motion relative to the base 830 about the joint 834.The biasing force from the contact arm 822 may be sufficient to maintainthe upper proximal wall 802 in a proximal first position. When a userdistally actuates the proximal wall 802, the axial force is sufficientto overcome the biasing force of the contact arm 822 and allow for thedistal movement of the proximal wall 802 away from its first position toa distal second position where the contacting arm 822 and contact pad824 are in contact for activation of the switch system and/or wake-up ofthe control system. Movement of the proximal wall 802 may occur relativeto the module housing that is in a fixed position during this action topower-on the system without an actuation force on the actuator. Movementof the proximal wall 802 may also occur relative to the module housingthat is in the process of moving to a final distal position during theactuation force on the actuator to cause dose delivery. The switchsystem 820 may include alternative switch configurations, such as, forexample, a mechanical switch or rubber dome switch.

Contact length arm portion 832 may extend from the base 830 at an acuteangle relative to a plan defined by the base 830, although the angle ofextension of the arm portion may be orthogonal or acute relative to thebase. From a radial view perspective, the contact arm may have aV-shaped body. In one example, any part of the arm portion 832 mayinclude a contacting portion contactable with the contact pad 824. Inone embodiment shown, the tip end 835 of the arm portion 832 defines thecontacting portion. In another embodiment, the contacting portion isalong the intermediate body of the arm portion 832. The contactingportion of the arm portion 832 may be configured for enhanced contactingthe contact pad 824, such as, for example, including a polished orsmoothed surface and/or a rounded surface or hook shape and/or a domedsurface (such as shown in FIGS. 35-36).

Any application force with the proximal wall 802 may move the contactarm from its natural state, to its contact configuration. In oneembodiment, the arm portion 832 may be angled along its body at abearing joint 837 to define a proximal extending first portion 840A anda distally extending second portion 840B. The first portion 840A extendsbetween the base 830 and joint 834 portion and the bearing joint 837.The second portion 840B extends between the bearing joint 837 and thetip end 835. The length and angle of extension of first portion 840A isconfigured to place the bearing joint 837 at a location to maintaincontact with the interior surface 802A of the proximal wall or the lightring, or alternatively corresponding bosses 802B extending distally fromsurface 802A, of the proximal upper wall 802 when moving between itsfirst and second positions. The length and angle of extension of secondportion 840B in the distal direction is configured to place the tip end835 in a spaced relationship with the contact pad 824 when the proximalwall 802 is at the first position, and to allow distal movement of thetip end 835, together with the proximal wall 802, for a sufficientdistance to contact the contact pad 824 when the proximal wall 802 is atthe second position. In an alternative embodiment, the bearing portion837 of the contact arm 822 may be located in closer proximity to the tipend 835 of the arm portion than the location of the contacting portion.To this end, the contacting portion may be formed along a valley orrecess of the arm portion. In some contact arm embodiments, the bearingportion of the contact arm is disposed in a more proximal location thanthe contacting portion.

From an axial view perspective, the configuration of the arm portion 832of contact arm 822 may be linear, angular, or curved. FIG. 36illustrates an example of the arm portion 832 having an arcuate shape.Although one contact arm and contact pad system may be sufficient forwake-up functionality of a module, FIG. 36 depicts the system includingthree sets of contact arms 822 and contact pads (not clearly shown inthe figure). As shown, the three contact arms 822 may be disposedradially from the longitudinal axis about the same distance. The arms822 may be disposed circumferentially spaced from one another at equaldistance, such as, for example, allowing for 20 to 40 degrees ofseparation between adjacent ends of the contact arms. Multiple sets,such as, two, three, four, five, or more, may distribute the biasingforce from the contact arms 822 to the upper wall 802 more evenly. Evenwith multiple sets, the controls may be configured to require one onlyset of contact arm 822 and contact pad 824 or less than all of the totalnumber sets to make contact for activation. Requiring less than thetotal amount of contacts for activation can allow the user to press anyportion of the proximal wall to cause wake-up, rather than requiring theuser accurate finger placement. To aid inadvertent activation, thecontrols may be configured to require more than one set, such as, forexample, all three sets, of contact arms 822 and contact pads 824 tomake contact for activation.

The base 830 and contact arm portion 832 may be formed integrally fromthe same material, such as, an electrically conductive material, such asmetal. The contact pad 824 is made of material conductive with thecontact arm. The base and arm portion may be formed separately from samematerials or different materials. If formed separately, the base and armportion may be coupled to one another, such as, for example, welding,metal welding epoxy, brazing, or other means depending on the materialsof the components. The base and arm portion may be formed from a plasticmaterial having conductive material impregnating the plastic material inat least the tip end portion or having a conductive material coatingalong the tip end. In one example, the base and arm portion is formedintegrally from an electrically conductive metallic material and arecoupled to one another at a living hinge joint such that the contact armhas a leaf spring configuration.

FIG. 37 shows another example of a module attachment subassembly, nowreferenced as spacer unit 839. Unit 839 is configured, when part of amodule, to permit the module 800 to be removably coupled to any of thedose buttons described herein via the attachment element 807. Distalwall 806 includes the aperture 836 defined therein for receiving a lightguide member 849 for the identification sensor, such as, for example,identification sensor 680 in FIG. 29. Vent opening 841 may be defined inthe distal wall 806. Sensor receiving recessed locations 842 are definedin the proximal surface of the distal wall 806 for equi-radially-spaced,and equi-angularly, placement of measurement sensors, e.g., for fivemagnetic, inductive, or capactive sensing elements or magnetic sensors906 as disclosed herein. Recesses 842 may be located in the distalsurface of distal wall 806. Attachment stakes 843 may be provided forcoupling distal wall 806 and/or unit 839 to a complementary attachmentfeature of the module housing.

With reference to FIG. 39, light guide member 849 is shown with a lightguide post 853 extending from a base 855. The light guide member beingmade of a material, such as an optically clear polycarbonate, thatpermits at least some light transmission therethrough for theidentification sensor to emit and sense light reflected from the coloredportion of the proximal surface of the button. The post 853 is sized tofit within the aperture 836. Shown in FIG. 38, a recessed region 857defined in the distal surface 806A of the distal wall 806 may surroundthe aperture 836. The recessed region 857 may have a depth and shape tocorrespond to the thickness and shape of the base 855. The aperture 836and the recessed region 857 may be sized and shaped to receive the lightguide member 849 in a secured manner. The axial length of extension canprovide a light guide path for the identification sensor from the distalsurface of the distal wall 806 that will abut against the coloredsurface feature of the device button proximally to directly contact thesensor, or there may be an axially spaced gap, as shown, between the endof the post 853 and light color sensor. The light guide post 853 has across-sectional shape of any one of a variety of geometric shapes, suchas circular, elliptical, or rectangular. In one example, the post 853has an elliptical cross-sectional shape. One or more attachment posts859 (two shown) may also proximally extend from the base 855. Eachattachment post 859 may be spaced radially from the light guide post853. To this end, the base 855 may include wing portions 855A toaccommodate the attachment post. A corresponding number of postapertures 863 may be defined in the distal wall 806 to receive theattachment posts 859 during manufacturing. Once received therein, theattachment posts may be heated, such as for example, through ultrasonicwelding, to allow material to fill voids the respective post aperturesfor a secure attachment to enhance consistent sensing capability.

Module 800 includes another embodiment of the attachment element 807.Although the attachment element 807 is illustratively shown, it shouldnot be limiting as module 800 can also be provided with the attachmentunit 500 or attachment element 419. Similarly, the other modulesdescribed herein may include the attachment element 807.

Attachment element 807 with the distal wall 806 may form a unit part ofthe module 800. Attachment element 807 may include a plurality ofdistally extending arms 850. In an exemplary embodiment, arms 850 areequi-angularly spaced around the dose button. Arms 850 are depicted asbeing coupled to and depending distally from the distal wall 806. Whenmodule is attached to the device, arms 850 are positioned to contact theradially outward facing surface of the dose button. Arms 850 include anaxial extending body 854. Body 854 may include a protruding bearingportion 852 extending radially-inward of the body 854. Body 854 of arms850 may include a W-shaped body, where outer distally extending legs856A-B of arm body extends from the distal wall 806 at two attachmentlocations and the proximal extending inner arm 858 includes theprotruding body 852. Surfaces of the protruding body of bearing portion852 may be orthogonal, curved and/or angled. Body 854 may,alternatively, include a J-shape having a portion that defines theproximally extending arm.

With additional reference to FIG. 35, battery 861 may provide shieldingproperties for the magnetic sensors and magnetic ring. In one example,the battery 861 may be a coin cell battery with a ferromagnetic nickelcoating. Placement of the battery 861 may be axially proximal to themagnetic sensors to provide shielding for the sensors, providingshielding along its proximal side to inhibit magnetic field influencesfrom the proximal direction, and/or providing shielding along its distalside deflecting the magnetic flux from the magnetic ring toward thesensors. In one example, battery 861 may assist in re-directing themagnetic flux lines, such as, from the ring, such as the rotation sensedelement 706, toward the position of sensors, such as sensors 906, and inre-directing the magnetic flux lines from unwanted external interferenceaway from sensor position. In this example, the size of the battery,such as the radius, may coincide with the radial location of the sensorsfrom the axis. In another example, the make-up of battery 861 mayprovide other shielding properties, such as the battery including iron(most series), cobalt or other nickel alloys with appropriatethicknesses. The battery 861 can have a cross-sectional area sizerelative to the radial placement of the magnetic sensors and/or can beaxially spaced from the magnetic sensors to provide such shielding.

Any of the modules described herein, such as, for example, module 800,can comprise five (shown) or six sensing elements, such as magneticsensors. The sensing elements may be disposed within the modulecompartment 808 and coupled to the circuit board 809 of the electronicsassembly 810 and thus to the MCU. In one example, the sensing elementscomprises five or six magnetic sensors disposed within correspondingsensor receiving recessed locations 842 defined within the distal wall806, as shown in FIG. 37, although the sensing elements may be disposedon top of the distal wall 806 (that is, not in recesses), or moreproximal to the distal wall 806 within the compartment of the module.

FIGS. 40-41 depict an example of an arrangement of the sensors relativeto the magnetic ring, and is illustrative for all other magnetic dosedetection systems described herein. FIG. 40 illustrates another exampleof the magnetic sensor system, now referred to as system 900, includingas the sensed element the diametrically magnetized ring 902 having thenorth pole 903 and the south pole 905. Magnetized ring 902 is attachedto the dose setting member, such as, for example the flange, aspreviously described. The radial placement of the magnetic sensors 906,such as, for example, hall-effect sensors, relative to the magnetizedring 902, can be in an equi-angularly relative to one another in a ringpattern. In one example, the magnetic sensors 906 are disposed radiallyin an overlapping relationship with the outer circumferential edge 902Aof the magnetized ring 902 such that a portion of the magnetic sensor906 resides over the magnetized ring 902 and the remaining portionresides outside the magnetized ring 902, such as shown in FIG. 40. Theoverlapping arrangement was found to place the sensors in the range forhigh flux capability and thus for more consistent magnetic flux sensing.FIG. 41 shows the radial distance 907 determined from the center of themagnetic sensor 906 to the axis AA. The radial distance 907 may be sizedto be at least the outer radius 908 of the magnetized ring 902. In oneexample, the radial distance 907 is 0.1-20% greater than the outerradius of the magnetized ring 902, and in another example, the radialdistance 907 is at least 10% greater than the outer radius of themagnetized ring 902. It has been surprising that this position canprovide enhanced peak magnetic flux for sensing over other radialpositions. FIG. 11A depicts another example of the relevant radialplacement with the magnetic sensors disposed entirely over the ring.FIG. 11B depicts another example of the relevant radial placement withthe magnetic sensors disposed entirely inside opening formed by thering.

FIG. 41 illustrates an example of an axial placement and a radialplacement of the magnetic sensors 906 relative to magnetized ring 902.Sensors 906 may be disposed along the circuit board 903 of theelectronics assembly of the module (module components omitted forclarity) that is disposed along a common plane that is substantiallyorthogonal to the axis AA. Magnetic ring 902 of a thickness 913 may bedisposed in a planar positon, parallel to the plane of the sensors 906.Ring 902 may be disposed in the device 720 arrangement, while the sensor906 may be disposed in the module that is removably attachable to thedevice. In an alternative example, the components of the module,including the sensors 906, may be permanently integrated with the devicewith magnetized ring 902 like what is shown in FIG. 12.

Geometry of the ring can be modified within available space constraintsto meet the magnetic flux performance requirements for the selectedsensors. FIG. 41 depicts the relative axial position 911 of the magneticsensors 906 over the magnetized ring 902 when the dose button isuncompressed, such as during dose setting. During dose delivery, therelative axial position of the magnetic sensors 906 over the magnetizedring 902 changes after distal displacement of the dose button andsensors 906 by a distance, shown by arrow 909, toward the rotatingmagnetized ring 902 that remains axially stationary. The amount ofdistal movement the magnetic sensors 906 can be in the range of 1 mm to3 mm relative to the magnetized ring 902. In one example, during use, asthe user applies pressure on the top of the module, the button/springsub-assembly undergoes axial compression, and reduces the relative axialdistance between sensor 906 and magnetized ring 902 by an axial distanceof 1.7 mm. At the dose delivery position, the magnetic flux ofmagnetized ring 902 available for reading by the sensors 906 is at leasttwice the value than when the sensors 906 are in the dose settingposition.

Magnet material for diametrically magnetized ring 902 should be selectedsuch that flux available at the dialing and dosing distances will beacceptable for reliable sensing. In one example, the magnetic ring usefor the sensed component, for example, may be made from sinteredNeodymium N35 grade material with nickel coating. A neodymium magnet(also known as NdFeB or NIB or Neo magnet) is a rare-earth permanentmagnet made from the alloy of neodymium, iron and boron. Other sinteredNeodymium magnet grades such as N42, N45, N50 and alike or bondedNeodymium grade (injection or compression molded with thermoplastic orthermoset) may be considered for the appropriate flux availability atthe magnetic sensors. The selected magnet material is expected to meetmechanical strength requirement for firmly fitting against the plasticcarrier, such as carrier 708, and sized to sustain operational andhanding impacts without cracks or failure. The secured magnetized ringis secured fixedly to the dose setting member to not rotate by itself,but does rotate with the dose setting member during dialing or dosing.

The axial movement of the sensors relative to the magnetized ring duringdose delivery and the change in the magnetic flux due to this axialposition change and due to rotation of the ring can make dose detectionaccuracy challenging. Also, more cost-effective diametrically magnetizedrings of sintered N35 Neo magnet can provide non-uniform magnetic fieldproperties, leading to greater inconsistent sensing detection and dialerror. The dial error of the module for dose detection is the rotationalposition difference in degrees between the actual physical rotationalposition of the device dose components, such as the magnetic ring, (“thedialed position”), and the sensed rotational position detected by themagnetic sensor system (“the detected position”). For example, when auser desires a certain number of units of drug to be delivered from thedevice, the user rotates the device button with the module attachedthereto relative to the device housing by an amount as indicated by thedosing dial, such as 10 units or approximately 180 degrees of rotationbased on 18 degrees ±X % per 1 unit. When the button is pressed to beginthe deliver operation, the dose detection system can track the initialposition and the final position at the completion of the dose delivery,in which the difference between initial and final positions correspondsto a number of degrees of rotation and correlated amount of dose unitsdelivered.

Dial error may be illustrated with the following example. The dialedinitial position may place the dose/dialed member of the device, andthus the magnetic ring, at a nominal zero initial physical positionafter dose setting has occurred, and a delivered final physical positionof the ring after rotation of 90 actual degrees, correlating to fiveunits during dose delivery. With dial errors, the dose detection systemin a four-sensor system with regular production diametrically magnetizedrings may detect −10 degrees for the nominal zero initial positon of thering, and 100 degrees for the delivered final position, resulting in atotal of 110 degrees of detected rotation of the ring. This wouldcorrespond to a sensed dose of over six units delivered, which isgreater than the five units actually delivered.

Dial errors can be introduced to the system from the magnetic sensorsand other factors. The first spatial harmonic waveform (mainwaveform/signal) can be susceptible to phase, gain or offset errorsduring rotation of magnetized ring relative to the sensors that measurea sine wave, with the number of sensors equally spaced around acircumference from one another and equally axially spaced from themagnet would represent the number of times the sine wave is sampled.Appropriate calibration of sensors may reduce these errorssignificantly. However, other error contributions can be from higherharmonics such as third or fourth harmonics to the first harmonic. Someerror can be reduced by consistent radial positioning of the magnetsensors from module axis, as well as consistent circumferential spacingbetween each of the sensors, reducing tilt of plane of co-locatedsensors to be substantially normal to module axis and in parallel to themagnetic ring, and calibration of the system.

Improving the uniformity of the flux in magnetic properties of thediametrically magnetized rings by using higher-grade magnetic materialsources, such as, for example, N50 grade Neodymium magnet, or tightermanufacturing controls, may reduce the dial error. Such improvedmagnetic components would be more expensive and limit the magnetsourcing capability. In addition, there was uncertainty as to whetherproviding additional magnet sensors (one or two more) that alreadyshowed non-uniform properties would improve the sensing capability. Ithas been discovered that that the use of five or six magnet sensors 906for the rotating diametrically magnetized ring 902 during dose deliveryimproved the position signals used for dose determination by properfiltering of offset second and third order harmonic signal distortionnormally present in regular production magnets, which led to thereduction of dial error. Such filtering was not present with the4-sensor architecture. To this end, improvement have been discovered toensure that the amount of units delivered detected by the dose detectionsystem corresponds to the actual amount of units delivered.

Regular production N35 Neo sintered diametrically magnetized rings weretested to determine harmonic distortion of sensor signals for second,third, fourth and fifth order harmonics percentage amplitude vs. firstorder harmonics. Results are shown in FIG. 42. A customized magnetictest fixture was built to emulate the magnet-sensor sub-system functionarranged in the modules described herein. The fixture is configured toadjust relative radial and circumferential position and axial (tilt outof plane) positions of the sensors and magnetic rings to not only testdifferent configuration, but also reproduce the axial and radialarrangement in FIG. 40 and FIG. 41. Results from individual sensors canbe analyzed to understand the effects of magnetic non-uniformity onharmonic distortions and dial/dose errors. Dial errors resulting from 4-vs. 5- and 6-sensor architectures for N35 grade magnets made fromregular production (more cost effective) and customized production (lesscost effective) methods are shown in FIGS. 43-44, respectively. FIG. 45illustrates the sensitivity of 4-sensor architecture with regularproduction N35 Neo sintered diametrically magnetized rings to thirdharmonics, leading to its susceptibility to the increase of dial errorsto over six degrees, and the immunity of 5-sensor architecture withregular production N35 Neo sintered diametrically magnetized rings tothird harmonics, leading to a substantial reduction to dial errors toless than two degrees.

FIG. 42 depicts the dial error of a 4-sensor architecture used withregular production N35 magnetic rings. The 4-sensor architecture hasbeen demonstrated to exhibit increased undesirable error contributionsfrom third harmonics affecting the reliability of the position signals.It was thought that the radially equidistant sensor configuration wouldbe immune to small amplitude variations from the magnetic flux of therotating magnetized ring. Numerical simulation of the 4- vs 5- and6-sensor architecture considering Neodymium magnet flux propertiesshowed that the addition of sensors equally spaced along thecircumference reduced higher order harmonics on angle measurement,thereby reducing the dialing and dosing error variations. Various testswith sintered N35 Neo magnets from regular production (ones originallyshowing non-uniform properties), sintered N35 magnets with customizedproduction methods (w/tighter controls), and sintered N50 Neo highergrade magnets were performed to compare the sensor architecture effectswith each other and to numerical modeling simulations, where it wasfound that third harmonics had the most influence on angle measurements.To this end, five sensor architecture was able to cancel up to the thirdharmonic distortion better than the four sensor architecture, while itis possible to cancel up to fourth harmonics with the six sensorarchitecture.

In FIG. 42, the effect of the error contributions from higher orderharmonics that lead to deviation of the measured rotational magneticflux waveform during rotational position sensing along 360 degrees (atline 1000) for a four-sensor architecture as compared to a calculatedmathematic desired model of the magnetic flux waveform during rotationalposition sensing (at line 1010) based on magnet geometry and itsproperties. Such deviation between the two lines 1000, 1010 maycontribute to dial errors in four-sensor systems.

From test data, the module with five or six magnetic sensors isconfigured to have significantly reduce the distortion error in a mannerthat it is likely to produce an acceptable dial error contribution fromthe magnet distortion from the sensor/ring arrangement that would be twodegrees or less. In one example, in FIG. 43, for a lot of regularproduction magnets, the dial error for a 4-sensor architecture was anaverage of 6.5 degrees (at line 1100). The dial error for 5-sensorarchitecture with similar regular production magnets was an average of1.2 degrees (at line 1110), respectively, and further an average of 0.5degrees with a 6-sensor architecture (at line 1120). Five-sensor or6-sensor architecture with regular production N35 magnetic rings isshown to have reduced the dial error by over five times compared to the4-sensor architecture. Five-sensor or 6-sensor architecture with customproduction magnets is shown to have reduced the error by over threetimes compared to the 4-sensor architecture. In FIG. 44, for customizedproduction magnets, the dial error reduced from average of 1.4 degreesto an average of 0.4 degrees from 4-sensor (at line 1200) to 5-sensorarchitecture (at line 1210), respectively, and to an average of 0.4degrees with a 6-sensor architecture (at line 1220).

FIG. 45 summarizes percentage harmonics variation from three lots (1301,1302, 1303) of N35 grade sintered magnetic rings produced by regularproduction method for 4-sensor and 5-sensor systems. The 4-sensorarchitecture (at line 1310) exhibited up to an average of 3.8 percentthird harmonics, while the 5-sensor architecture (at line 1320)exhibited an approximately zero percent at the third harmonics. The5-sensor architecture (at line 1320) exhibited up to an average of 0.8percent fourth harmonics, while the 4-sensor architecture (at line 1340)was exhibited an approximately zero percent at the fourth harmonics. Thecontribution of third harmonics to the main waveform is what resulted inthe dial error in the 4-sensor architecture to over six degrees, asshown in FIG. 43, while the improvement to the main waveform with thereduction of third harmonics with the addition of sensors to 5-sensor or6-sensor architecture, resulting in a reduced dial error below twodegrees as shown in FIG. 43.

Further illustrative embodiments of a dose delivery detection system areprovided in FIGS. 30-34. The embodiments are shown in somewhatdiagrammatic fashion, as common details have already been provided withrespect to FIGS. 1-5. Described herein are several exemplary embodimentsof medication delivery devices utilizing magnetic sensing of dosedelivery. The ring-shaped element, such as, for example, magnet or metalring, may be fixedly secured to the dose dial member and/or flange of adevice by various attachment means, such as adhesives, welding, ormechanical attachments. For high volume manufacturing, the attachmentmeans may be beneficial. In FIGS. 30-34 there is shown an illustrativemanner of mounting a ring-shaped element to a flange forming a part of amedication delivery device. FIG. 30 illustrates the components in axialalignment that are coupled to one another as an integral single unit (asshown in FIG. 31) which rotates and axial moves as a single unit,including: the dial member 700, an exemplary clutch 702, a dose settingcomponent, such as, for example, flange 704, to receive a rotationsensed element 706, a carrier 708 to fixedly couple the rotation sensedelement 706 to the flange 704, a button spring 710 for biasing a dosebutton 712. Instead of the flange, other dose setting componentsdescribed herein may be used. Dose button 712 may have the configurationof any of the buttons described herein. Referring to FIG. 31 and aspreviously described with respect to FIGS. 1-4, medication deliverydevice 720 includes dial member 700 mounted within device body 722.Flange 704 is received within dose dial member 700, and clutch 702 ispositioned within flange 704. Dose dial member 700, flange 704 arerotationally fixed together and rotate during dose setting and/or dosedelivery in direct relation to the amount of a set or delivered dose.Clutch 702 includes stem 724 to which is mounted dose button 712. Spring710 acts between dose button 712 and flange 704 to bias dose button 712proximally away from flange 704. As previously described, the medicationdelivery device is further provided with a rotation sensed elementattached to the flange such as the sensor is housed entirely within thedose button. Any of the modules described herein includes theelectronics assembly and the sensing elements to detect rotation of therotation sensed element 706 during dose setting and/or delivery todetermine the amount of dose involved.

Flange 704 is generally cylindrical in shape and defines a proximalaxial surface 732 at the end of sidewall 734. Flange 704 further definesa central opening 736 that is interior of proximal surface 732. As shownin FIG. 32, the rotational sensor 706 has an annular shape, such as anannular magnet, metal ring, or magnetized or metalized polymer ring, ispositioned on proximal surface 732 of flange 704. Carrier 708 includesan overlapping proximal lip or support 742 which is positioned againstthe proximal surface of the rotational sensor 706 opposite proximalsurface 732 to sandwich the sensor 706 therebetweeen. Support 742 isshown as a generally ring-shaped component, however it may alternativelycomprise a segmented ring or a plurality of supports spaced aboutrotational sensor 706.

In this configuration, carrier 708 retains sensor 706 in position on topof flange 704 by having support 742 bear distally against sensor 706.This is accomplished by having carrier 708 fixed axially relative toflange 704. In one embodiment, carrier 708 is attached directly toflange 704, for example at a location distal of sensor 706. In anotherillustrative embodiment, carrier 704 is spring-biased in a distaldirection, such as by spring 710 urging carrier 708 away from dosebutton 712, or by a spring acting to pull carrier 704 toward flange 704.

Referring back to FIG. 30, carrier 708 includes a tubular body 750 witha plurality of axially extending legs 752 circumferentially spaced fromone another about a generally axial bore 754 that extends through thecarrier. Body 750 includes support 742 sized to capture the rotationsensed element 706 against the flange. Body 750 is sized to receive theinner diameter or cross-sectional area of the sensor 706. As shown inFIG. 31, the support 742 extends radially outward beyond the size of thebody 750. The portions of the body 750 with the legs 772 dependingtherefrom may include a snap radial lip 771 positioned distal away fromthe support 742 to the size of the axial thickness of the sensor 706 toengage the distal surface of the sensor 706. Each of the legs 772includes a radially inward protruding element 756 sized and shaped forinsertion within corresponding suitably sized axial slots 760 formed inthe sidewall 734 of the flange, as illustrated in FIG. 34. Slots may besized to snugly receive the element 756 such that through frictionalengagement the two component are rotationally locked and torque istransmitted therebetween.

The radial ends of the element 756 may be in engagement with a centralhub of the flange 704 as shown in FIG. 31 and FIG. 33. As shown in FIG.31, in one approach, legs 752 of carrier 708 define a circumferentialcross-sectional span sized for secure frictional engagement along thecylindrical interior surface 759 of the flange 704 when inserted withinthe opening 736 of flange 704. In one example, legs 752 extend withincentral opening 736, and in one approach are directly attached to flange704 at a location distal of sensor 706. The relevant placement of thespring 710 is shown in FIGS. 31 and 33. Flange 704 may include a radialslot 762 formed in its proximal axial surface 732. Slots 760 are formedin the flange in a manner such that the interior surface of the legs 752are in close alignment with the interior surface of the outer wall thatdefines the radial slot 762, as shown in FIG. 31. In this configuration,the distal end of spring 710 is positioned to within the radial slot762. The walls defining the radial slot 762 support the distal end ofspring 710 and allows bearing against the dose button at the mountingcollar, thereby urging carrier 708 in a distal direction away from thedose button.

The various components of carrier 708 may comprise either partial orfull circumferential members. For example, the body of the carrier 708may extend fully around the flange, or may be formed as spaced segments.Advantageously, use of the carrier means that rotation sensed element isheld firmly in place without the use of adhesives. Although adhesivesmay be used, adhesives can complicate the fabrication process.

Electronics assembly 610 includes a variety of operably connectedcomponents for module 600 as well as any of the other modules describedherein, including a battery 621 for power source and associatedcontacts, MCU for executing programmed instructions, memory for storingprograms and data, a communications assembly for transmitting and/orreceiving data, timer for tracking time, and various switches andsensors as described. Any of the modules described herein, such as, forexample, modules 82, 232, 400, or 600, may be configured to house any ofthe electronics assemblies described herein, including being configuredto house the sensing elements 160 for use with the sensor system 150described previously.

FIG. 46 illustrates an example of the electronics assembly, referred toas 1400, which can be included in any of the modules described herein.MCU is programmed to achieve the electronic features of the module. MCUincludes control logic operative to perform the operations describedherein, including obtaining data used for determining a dose deliveredby medication delivery device based on a detected rotation of the dosedelivery member relative to the actuator. MCU may be operable to obtaindata by determining the amount of rotation of the rotation sensedelement fixed to the flange, which is determined by detecting themagnetic field of the rotation sensed element by the sensing elements ofthe measurement sensor, such as, for example, Hall Effect sensors, ofthe system.

Assembly includes MCU that can be operably coupled to one or more ofdose sensors 1402A-E, memory 1408, identification sensor 1404, counter1414, light driver 1411 and light indicators 1412, power-on module 1406,communication module 1410, display driver/display 1416, power source1418, and presence module 1420. Assembly 1400 may include any number ofdose sensors, such as, for example, five magnetic sensors 1402A-E(shown) or six sensors. MCU is configured to determine the total unitsof rotation. MCU may be configured via the presence module 1420, shownin this embodiment to be optional by dashed lines, to determine via thetriggering of the presence switch system whether the module is coupledto the device's button. MCU is configured to determine the color of thedose button via the identification sensor 1404, and in some examples,associate the color data determined onboard, or off board with anexternal device, the color corresponding to a particular medication. MCUis configured to determine triggering of the wake-up switch in order topower on the electronic assembly for use, shown as power-on module 1406.In one example, the total rotation may be communicated to an externaldevice that includes a memory having a database, look up table, or otherdata stored in memory to correlate the total rotational units to anamount of medication delivered for a given medication identified. Inanother example, MCU's may be configured to determine the amount ofmedication delivered. MCU may be operative to store the detected dose inlocal memory 1408 (e.g., internal flash memory or on-board EEPROM). MCUis further operative to wirelessly transmit a signal representative ofdevice data, such as, for example, (any one or any combination thereof)the rotational units, medication identification (such as color) data,timestamp, time since last dose, battery charge status, moduleidentification number, time of module attachment or detachment, time ofinactivity, and/or other errors (such as for example dose detectionand/or transmission error, medication identification detection and/ortransmission error), to a paired remote electronic device, such as auser's smartphone, over a Bluetooth low energy (BLE) or other suitableshort or long-range wireless communication protocol module 1410, suchas, for example, near-field communication (NFC), WIFI, or cellularnetwork. Illustratively, the BLE control logic and MCU are integrated ona same circuit. In one example, any of the modules described herein,such as module 600, may include the display module 1420, shown in thisembodiment to be optional by dashed lines, for indication of informationto a user. Such a display, which may be LEDs, LCD, or other digital oranalog displays, may be integrated with proximal portion finger pad. MCUincludes a display driver software module and control logic operative toreceive and processed sensed data and to display information on saiddisplay, such as, for example, dose setting, dosed dispensed, status ofinjection, completion of injection, date and/or time, or time to nextinjection. In another example, MCU includes a LED driver 1411 coupled toone or more LEDS 1412, such as, for example, RGB LED, Orange LED andGreen LED, used to communicate by sequences of on-off and differentcolors to the patient of whether data was successfully transmitted,whether the battery charge is high or low, or other clinicalcommunications. Counter 1414 is shown as a real time clock (RTC) that iselectronically coupled to the MCU to track time, such as, for example,dose time. Counter 1414 may also be a time counter that tracks secondsfrom zero based on energization. The time or count value may becommunicated to the external device.

The dose detection systems have been described by way of example withparticular designs of a medication delivery device, such as a peninjector. However, the illustrative dose detection systems may also beused with alternative medication delivery devices, and with othersensing configurations, operable in the manner described herein. Forexample, any one or more of the various sensing and switch systems maybe omitted from the module.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character. For example, devicesensing module can sense dose setting amounts if adapted to work with adevice portion having suitable parts that experience relative rotationduring dose setting. This application is therefore intended to cover anyvariations, uses or adaptations of the invention using its generalprinciples. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this invention pertains. All changes,equivalents, and modifications that come within the spirit of theinventions defined by the claims included herein are desired to beprotected.

Various aspects are described in this disclosure, which include, but arenot limited to, the following aspects:

1. A dose detection module for removable attachment to a dose button ofa medication delivery device, the dose button having a cylindricalbutton sidewall, the device including a sensed component ring rotatableduring dose dispensing, the module including: a housing including aproximal wall assembly, a distal wall, and a module sidewall extendingtherebetween about a module longitudinal axis to define an interiorcompartment, the module sidewall extending distally beyond the distalwall, the distal wall defining a plurality of recesses disposedequi-angularly relative to one another, the housing configured to couplearound the button sidewall; and an electronics assembly including aprocessor and a plurality of sensors operably coupled to the processor,wherein each of the sensors are disposed securely within correspondingrecesses, wherein the sensors are configured to detect rotationalmovement of the sensed component ring to generate position signals, theprocessor configured to receive the position signals in order todetermine data indicative of an amount of dose dispensed based on theposition signal.

2. The module of aspect 1, wherein the sensed component ring includes abipolar magnetic ring, and the sensors includes magnetic sensorsdisposed at an arrangement to overlap an outer circumference of thebipolar magnetic ring.

3. The module of aspect 2, wherein the magnetic sensors include five orsix magnetic sensors.

4. The module of any one of aspects 1-3, wherein the housing includes alight guide member, and the distal wall defining a post opening, thelight guide member including a light guide post proximally extendingthrough the post opening beyond the magnetic sensors, wherein theelectronics assembly includes a color sensor disposed over the lightguide post and axially spaced therefrom, the color sensor operablycoupled to the processor and configured to emit and/or detect color ofthe dose button.

5. The module of aspect 4, wherein the light guide member is fixedlysecured to the distal wall.

6. The module of aspect 5, wherein the light guide member includes oneor more attachment posts radially spaced from the light guide post, thedistal wall including an light guide aperture receiving the light guidepost, and one or more attachment apertures receiving the correspondingnumber of attachment post.

7. The module of any one of aspects 1-6, the electronics assemblyfurther includes a battery operably coupled to the processor, and anaxially compressible battery support element in frictional contact withthe proximal side of the battery.

8. The module of aspect 7, wherein the battery has a cross-sectionalarea relative to a radial placement of the sensors and being axiallyspaced from the sensors to provide shielding to the sensors.

9. The module of any one of aspects 1-8, further including a switchsystem configured to increase power to the electronics assembly, whereinthe proximal wall assembly is axially movable relative to the modulesidewall and the distal wall to activate the switch system by a forceless than a force required for dose delivery from actuation of thedevice.

10. The module of aspect 9, wherein the switch system includes at leastone set of a biased contacting arm extending between the electronicsassembly and the proximal wall assembly, and a corresponding contact padoperably coupled to the processor, wherein the proximal wall assembly isaxially movable relative the housing between a first proximal position,wherein the contacting arm and the contact pad are not in contact withone another, and a second distal position, wherein the contacting armand the contact pad are in a contacting relationship to permit theincrease of power to the electronics assembly.

11. The module of aspect 10, wherein the switch system includes aplurality of sets of the contacting arm and the corresponding contactpad, each of the sets circumferentially disposed relative to one anotherequally apart, wherein one of the sets in the contacting relationship isconfigured to permit the increase of power to the electronics assembly.

12. The module of aspect 9, wherein the housing further includes anaxially compressible member coupled between the proximal wall assemblyand a housing portion to bias the proximal wall assembly in a proximalposition.

13. The module of any one of aspects 1-12, wherein the proximal wallassembly includes a light guide ring and a white or reflective surfacedisposed over an opening defined by the light guide ring, the lightguide ring including retention arms coupled to a housing portion of thehousing, the electronics assembly including a light indicator elementoperably coupled to the processor to emit light at the light guide ring.

14. The module of aspect any one of aspects 1-13, wherein the housingincludes a plurality of radially flexible arms extending from the distalwall, angularly spaced from one another, each of the arms having aproximally extending bearing portion.

15. A dose detection system including: a medication delivery devicehaving a magnetic ring fixedly coupled to a dosing member and rotatableduring dose setting and dose dispensing; and an electronics assemblyincluding a processor and a plurality of magnetic sensors operablycoupled to the processor, the magnetic sensors in an overlappingposition relative to an outer circumference of the magnetic ring,wherein the magnetic sensors are securely fixed relative to theprocessor, the magnetic sensors axially and rotatably locked with themagnetic ring during dose setting, and axially and rotatably freerelative to the magnetic ring during dose dispensing, the magneticsensors being equi-angularly disposed relative to one another to definea ring pattern, wherein in dose dispensing the magnetic sensors aredistally moved closer to the magnetic ring and remain stationaryrelative to the rotating magnetic ring to detect rotational movement ofthe magnetic ring in order to generate position signals, the processorconfigured to receive the position signals in order to determine dataindicative of an amount of dose dispensed based on the position signal.

16. The system of aspect 15, wherein the plurality of magnetic sensorsincludes five or six magnetic sensors, and the magnetic ring includes abipolar magnetic ring.

17. The system of any one of aspects 15-16, wherein each of the magneticsensors is spaced equi-radially at a radial distance defined from acenter of the magnetic sensor to the module axis, the radial distancesized to be equal to a distance of an outer radius of the magnetic ring.

18. The system of any one of aspects 15-17 further including a modulehousing including a proximal wall assembly, a distal wall, and asidewall coupled therebetween to define an interior compartment in whichthe electronics assembly is disposed, the distal wall defining aplurality of recesses in which magnetic sensors are disposed.

19. The system of aspect 18, wherein the module housing includes a lightguide member, and the distal wall defining a post opening, the lightguide member including a light guide post proximally extending throughthe post opening beyond the magnetic sensors, wherein the light guidemember is fixedly secured to the distal wall.

20. The system of any one of aspects 18-19, wherein the electronicsassembly further includes a battery disposed proximal to the magneticsensors and operably coupled to the processor.

21. The system of aspect 20 further including an axially compressiblebattery support element in frictional contact with a proximal side ofthe battery.

22. The system of any one of aspects 18-21, further including a switchsystem configured to increase power to the electronics assembly, whereinthe proximal wall assembly is axially movable relative to the sidewalland the distal wall to activate the switch system.

23. The system of aspect 22, wherein the switch system includes at leastone set of a biased contacting arm and a corresponding contact pad, thebiased contacting arm extends between the electronics assembly and theproximal wall assembly to bias the proximal wall assembly in a proximalposition, the contacting arm including an angled joint engaging theproximal wall assembly and a distally extending tip, the contact padcoupled to the electronics assembly and operably coupled to theprocessor, wherein the proximal wall is axially movable relative themodule housing to a distal position so that the tip and the contact padare in a contacting relationship to permit the increase of power to theelectronics assembly.

24. The system of any one of aspects 18-23, wherein the proximal wallassembly includes a light guide ring, and the electronics assemblyincludes a light indicator element operably coupled to the processor toemit light at the light guide ring.

25. The system of aspect 24, wherein the light guide ring includesretention snap arms coupled to a housing portion, wherein the modulehousing further includes a compressible gasket coupled between the lightguide ring and a first spacer element to bias the proximal wall assemblyin a proximal position.

26. The system of aspect 24, wherein the proximal wall assembly includesan element having a white or reflective surface disposed over an openingdefined by the light guide ring.

27. The system of aspect any one of aspects 18-26, wherein the modulehousing includes a plurality of radially flexible arms extending fromthe distal wall, the arms having a proximally extended portionconfigured to allow for attachment and detachment of the module housingfrom the device.

28. The system of any one of aspects 15-27, wherein the magnetic ringincludes a bipolar magnetic ring, wherein a contribution to a dial errorfrom the magnetic sensors and bipolar magnetic ring arrangement is twodegrees or less, wherein the dial error is a difference between a dialedpositon corresponding to a physical rotational position of the bipolarmagnetic ring and a detected positon corresponding to a sensedrotational position of the bipolar magnetic ring sensed by the magneticsensors.

29. A module for removable attachment to a dose button of a medicationdelivery device, the dose button having a cylindrical sidewall and a topwall having an upper surface, the dose button further including a radiallip extending outward at the top wall beyond the cylindrical sidewall,the module including: a housing including a proximal wall, a distalwall, and a perimetric sidewall extending between and forming acompartment with the proximal and distal walls; an electronics assemblyreceived within the housing compartment, the electronics assemblyincluding a processor and a measurement sensor operably coupled to theprocessor; and a plurality of arms coupled to and extending distallyfrom the housing, each of the arms including a bearing portion extendingradially-inward of the arm, each of the arms sized to extend distallybeyond the radial lip of a dose button to position the bearing portionin engagement with a cylindrical sidewall of the dose button at anengagement location that is distal to the radial lip of the dose buttonwhen the module is attached thereto, wherein each of the arms isconfigured to flex radially outward to clear the radial lip when themodule is attached to or detached from the device, wherein each of thearms is configured to apply a radially inward force at the engagementlocation against the cylindrical sidewall when the module is attachedthereto.

30. The module of aspect 29 in which the distal wall has a distalsurface configured to be received against the upper surface of the dosebutton when the module is attached thereto.

31. The module of any one of aspects 29-30 in which the arms areequi-radially spaced from one another.

32. The module of aspect 31 in which the arms are attached to a wall ofthe housing.

33. The module of aspect 32 in which the arms are formed having aJ-shape.

34. The module of aspect 31 in which the bearing portions of the armsinclude a surface configured to be received against or in closeproximity to an underside of the radial lip of the dose button when themodule is attached thereto.

35. The module of aspect 31 in which the arms are integrally formed withthe distal wall.

36. The module of any one of aspects 29-35 in which the arms areconfigured such that a detachment force to remove the module from thedose button is at least twice an attachment force to mount the module tothe dose button.

37. The module of any one of aspects 29-36 further including a wake-upswitch system including a movable segment disposed within and axiallymovable relative to the proximal wall of the housing, and a wake-upswitch operably coupled to the processor.

38. The module of aspect 37, wherein the wake-up switch system includesa flexible shroud disposed between the movable segment and the wake-upswitch wherein the shroud includes a plurality of radially extendinglegs.

39. The module of aspect 38 wherein the legs include a first set offixed legs and a second set of free legs.

40. The module of any one of aspects 29-39 further including a presenceswitch system including a presence switch and a biased axial actuatorslidably disposed within an opening defined by the distal wall of thehousing.

41. The module of aspect 40 wherein the axial actuator includes an outerradial rim positioned to trigger a switch arm of the presence switchwhen the module is detached from the dose button.

42. The module of any one of aspects 29-41 further including amedication identification system configured to detect data indicative ofa type of medication of the device.

43. The module of aspect 42 wherein the medication identification systemincludes an RGB sensor operably coupled to the processor, wherein thedistal wall of the housing includes an aperture defined therein, theaperture positioned axially over the RGB sensor to allow color detectionof the upper surface of the dial button when the module is attachedthereto.

44. The module of any one of aspects 29-43 wherein the electronicsassembly includes a first segment, a second segment, and a third segmentelectrically coupled to one another, wherein the third segment isdisposed between the first and second segments.

45. The module of aspect 44 wherein the first segment of the electronicsassembly includes a wake up switch operably mounted thereon, and thethird segment includes a medication identification sensor operablymounted thereon.

46. The module of any one of aspects 29-45 further including sensorrecesses defined in the distal wall of the housing, the measurementsensor including a plurality of magnet sensors equi-angularly spacedfrom one another and each magnet sensor disposed within a correspondingsensor recess.

47. A medication delivery system including: a medication delivery deviceincluding a device body and a dose button disposed at a proximal portionof the device body, the dose button having a cylindrical sidewall and atop wall having an upper surface, the dose button further including alip formed by extension of the top wall radially-outward of thecylindrical sidewall, the dose button including a rotation sensor and acarrier coupled to the rotation sensor; and a module mounted to themedication delivery device, the module including a housing including aproximal wall, a distal wall, and a perimetric sidewall extendingbetween and forming a compartment with the proximal and distal walls; asensor assembly received within the housing compartment, the sensorassembly including an electronics assembly including a measurementsensor configured to detect movement of the rotation sensor, a battery,a memory, a processor, and a communication assembly; and a plurality ofarms coupled to and extending distally from the housing, each of thearms including a bearing portion extending radially-inward of the arm,wherein, when the module is mounted to the dose button, each of the armsextending distally beyond the radial lip of the dose button to positionthe bearing portion in engagement with the cylindrical sidewall of thedose button at an engagement location that is distal to the radial lipof the dose button, and each of the arms is configured to apply aradially inward force at the engagement location against the cylindricalsidewall, wherein each of the arms is configured to flex radiallyoutward to clear the radial lip when the module is removed from thedevice.

48. The system of aspect 47 wherein an axial extension of the armsbeyond the distal wall to locate the bearing portion along a proximalportion of the sidewall of the dose button.

49. The system of any one of aspects 47-48 wherein an engagement surfaceof the bearing portion is sized axially larger than an axial thicknessof the radial lip.

We claim:
 1. A dose detection module for removable attachment to a dosebutton of a medication delivery device, the dose button having a buttonsidewall, the device comprising a sensed component ring rotatable duringdose dispensing, said module comprising: a housing including a proximalwall assembly, a distal wall, and a module sidewall extendingtherebetween about a module longitudinal axis to define an interiorcompartment, the module sidewall extending distally beyond the distalwall, the distal wall defining a plurality of recesses disposedequi-angularly relative to one another, the housing configured to couplearound said button sidewall; and an electronics assembly comprising aprocessor and a plurality of sensors operably coupled to the processor,wherein each of the sensors are disposed securely within correspondingrecesses, wherein the sensors are configured to detect rotationalmovement of the sensed component ring to generate position signals, theprocessor configured to receive the position signals in order todetermine data indicative of an amount of dose dispensed based on theposition signal, wherein the sensed component ring comprises a bipolarmagnetic ring, and the sensors comprise magnetic sensors disposed at anarrangement to overlap an outer circumference of said bipolar magneticring.
 2. The module of claim 1, wherein said magnetic sensors comprisefive or six magnetic sensors.
 3. The module of claim 1, wherein thehousing includes a light guide member, and the distal wall defining apost opening, the light guide member including a light guide postproximally extending through said post opening beyond the magneticsensors, wherein the electronics assembly comprises a coloridentification sensor disposed over the light guide post and axiallyspaced therefrom, said color identification sensor operably coupled tothe processor and, wherein when the module is attached to the dosebutton, said color identification sensor is configured to emit and/ordetect color of said dose button after reflection of light from the dosebutton.
 4. The module of claim 3, wherein the light guide member isfixedly secured to the distal wall.
 5. The module of claim 4, whereinthe light guide member includes one or more attachment posts radiallyspaced from the light guide post, the distal wall including-one or moreattachment apertures receiving a corresponding one of the attachmentposts.
 6. The module of claim 1, the electronics assembly furthercomprises a battery operably coupled to the processor, and an axiallycompressible battery support element in contact with a proximal side ofthe battery.
 7. The module of claim 6, wherein said battery has across-sectional area relative to a radial placement of said sensors andbeing axially spaced from said sensors to provide shielding to thesensors.
 8. The module of claim 1, further comprising a switch systemconfigured to increase power to the electronics assembly, wherein theproximal wall assembly is axially movable relative to the modulesidewall and the distal wall to activate the switch system by a forceless than a force required for dose delivery from actuation of thedevice.
 9. The module of claim 8, wherein the switch system comprises atleast one set of a biased contacting arm and a corresponding contactpad, the biased contacting arm extending between the electronicsassembly and the proximal wall assembly, and the corresponding contactpad operably coupled to the processor, wherein the proximal wallassembly is axially movable relative the housing between a firstproximal position, wherein the biased contacting arm and thecorresponding contact pad of the at least one set are not in contactwith one another, and a second distal position, wherein the biasedcontacting arm and the corresponding contact pad of the at least one setare in a contacting relationship to permit the increase of power to theelectronics assembly.
 10. The module of claim 9, wherein the at leastone set of the biased contacting arm and the corresponding contact padcomprises a plurality of sets of the biased contacting arm and thecorresponding contact pad, each of the sets circumferentially disposedrelative to one another equally apart, wherein one of the sets in thecontacting relationship is configured to permit the increase of power tothe electronics assembly.
 11. The module of claim 8, wherein the housingfurther comprises an axially compressible member coupled between theproximal wall assembly and a housing portion to bias the proximal wallassembly in a proximal position.
 12. The module of claim 1, wherein theproximal wall assembly includes a light guide ring and a white orreflective surface disposed over an opening defined by the light guidering, the light guide ring including retention arms coupled to a housingportion of the housing, the electronics assembly including a lightindicator element operably coupled to the processor to emit light at thelight guide ring.
 13. The module of claim 1, wherein the housingincludes a plurality of radially flexible arms extending from the distalwall, angularly spaced from one another, each of the arms having aproximally extending bearing portion.
 14. The module of claim 1, whereinthe recesses are defined in an axially facing surface of the distalwall, and the magnetic sensors are axially and rotatably locked with thebipolar magnetic ring during dose setting, and axially and rotatablyfree relative to the bipolar magnetic ring during dose dispensing, themagnetic sensors being equi-angularly disposed relative to one anotherto define a ring pattern, wherein in dose dispensing the magneticsensors are distally moved closer to the bipolar magnetic ring andremain stationary relative to the rotating bipolar magnetic ring todetect rotational movement of the bipolar magnetic ring in order togenerate position signals.
 15. The module of claim 14, wherein themagnetic sensors comprise five or six magnetic sensors.
 16. The moduleof claim 14, wherein each of the magnetic sensors is spacedequi-radially at a radial distance defined from a center of the magneticsensor to the module axis, the radial distance sized to be equal to adistance of an outer radius of the bipolar magnetic ring.
 17. The moduleof claim 14, wherein the housing includes a light guide member, and thedistal wall defining a post opening, the light guide member including alight guide post proximally extending through said post opening beyondthe magnetic sensors, wherein the light guide member is fixedly securedto the distal wall.
 18. The module of claim 14, wherein the electronicsassembly further comprises a battery disposed proximal to the magneticsensors and operably coupled to the processor.
 19. The module of claim18 further comprising an axially compressible battery support element incontact with a proximal side of the battery.
 20. The module of claim 14,further comprising a switch system configured to increase power to theelectronics assembly, wherein the proximal wall assembly is axiallymovable relative to the module sidewall and the distal wall to activatethe switch system.
 21. The module of claim 20, wherein the switch systemcomprises at least one set of a biased contacting arm and acorresponding contact pad, the biased contacting arm extends between theelectronics assembly and the proximal wall assembly to bias the proximalwall assembly in a proximal position, the contacting arm including anangled joint engaging the proximal wall assembly and a distallyextending tip, the contact pad coupled to the electronics assembly andoperably coupled to the processor, wherein the proximal wall is axiallymovable relative the module housing to a distal position so that saidtip and the contact pad are in a contacting relationship to permit theincrease of power to the electronics assembly.
 22. The module of claim14, wherein the proximal wall assembly includes a light guide ring, andthe electronics assembly includes a light indicator element operablycoupled to the processor to emit light at the light guide ring.
 23. Themodule of claim 22, wherein the light guide ring includes retention snaparms coupled to a housing portion of the housing, wherein the housingfurther comprises a compressible gasket coupled between the light guidering and a first spacer element to bias the proximal wall assembly in aproximal position.
 24. The module of claim 22, wherein the proximal wallassembly includes an element having a white or reflective surfacedisposed over an opening defined by the light guide ring.
 25. The moduleof claim 14, wherein a contribution to a dial error from the magneticsensors and the bipolar magnetic ring arrangement is two degrees orless, wherein the dial error is a difference between a dialed positioncorresponding to a physical rotational position of the bipolar magneticring and a detected position corresponding to a sensed rotationalposition of the bipolar magnetic ring sensed by the magnetic sensors.26. The module of claim 1, wherein the module housing includes aplurality of radially flexible arms extending from the distal wall.